Zimmer Dental Inc: 33 FDA recall reports
Every medical device recall the FDA has published for Zimmer Dental Inc. The fault, and how the agency graded it.
33Reports
0Class I
0Ongoing
2018-09-12Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only;
Z-2963-2018 · Class II · reported 2018-09-12 · Terminated
- Why it was recalled
- Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
- Product
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.
- How much
- 299 units
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Z-1189-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Product
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
- Where it went
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
- How much
- 995 distribution events total
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Z-1190-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Product
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
- Where it went
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
- How much
- 995 distribution events total
Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., C
Z-0279-2018 · Class II · reported 2017-12-27 · Terminated
- Why it was recalled
- The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
- Product
- Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Where it went
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
- How much
- 356 units
Tapered Screw-Vent MTX Model TSVTB11
Z-0284-2018 · Class II · reported 2017-12-27 · Terminated
- Why it was recalled
- Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
- Product
- Tapered Screw-Vent MTX Model TSVTB11
- Where it went
- US, Canada, France, Italy, Spain, Germany
- How much
- 500 units
Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the produ
Z-0280-2018 · Class II · reported 2017-12-27 · Terminated
- Why it was recalled
- The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
- Product
- Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Where it went
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
- How much
- 30 kits
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. Th
Z-0282-2018 · Class II · reported 2017-12-27 · Terminated
- Why it was recalled
- The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
- Product
- Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Where it went
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
- How much
- 891 kits
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The
Z-0281-2018 · Class II · reported 2017-12-27 · Terminated
- Why it was recalled
- The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
- Product
- Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Where it went
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
- How much
- 166 kits
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,AN
Z-3210-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 169 products
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Z-3204-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 349 products
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; C
Z-3206-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 13,235 products
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT
Z-3209-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 423 products
TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMEN
Z-3207-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 76 products
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5
Z-3208-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 86 products
THREAD RETRIEVAL DRILL REF 2224
Z-3205-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- Product
- THREAD RETRIEVAL DRILL REF 2224
- Where it went
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- How much
- 237 products
Tapered SwissPlus Implant System, Model No. SPB10
Z-1823-2017 · Class II · reported 2017-04-26 · Terminated
- Why it was recalled
- It was manufactured with the minor diameter of the internal thread that is below specification.
- Product
- Tapered SwissPlus Implant System, Model No. SPB10
- Where it went
- Worldwide: ZA, FR, IT, IR
- How much
- 188 units
IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental impla
Z-0778-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant s
Z-0776-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant
Z-0773-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant sys
Z-0777-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental impl
Z-0782-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are
Z-0775-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1050
IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant sy
Z-0774-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1050
IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental imp
Z-0779-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant sy
Z-0772-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implan
Z-0784-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implan
Z-0783-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Dental implan
Z-0781-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental impla
Z-0780-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
- Product
- IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Where it went
- Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
- How much
- 1059
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Sys
Z-1115-2015 · Class II · reported 2015-02-18 · Terminated
- Why it was recalled
- The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
- Product
- GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.
- Where it went
- Worldwide Distribution -- US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain
- How much
- 627 units
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls