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Zimmer Manufacturing B.V.
Zimmer Manufacturing B.V.: 91 FDA recall reports
Every medical device recall the FDA has published for Zimmer Manufacturing B.V.. The fault, and how the agency graded it.
91Reports
0Class I
0Ongoing
2016-05-25Most 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.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Z-1682-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 50
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm lengt
Z-1681-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 50
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550
Z-1684-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 3893
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN I
Z-1678-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 219
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Can
Z-1677-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping,...
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 3955
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
Z-1675-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 200
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20
Z-1683-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 1199
Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
Z-1674-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 100
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bo
Z-1680-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 90
Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical
Z-1673-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 794
Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20
Z-1679-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length 00114205124 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length 00114205128 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length 00114205130 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length 00114205138 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length 00114205148 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length 00114205165 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm...
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 751
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm leng
Z-1676-2016 · Class II · reported 2016-05-25 · Terminated
- Why it was recalled
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Product
- Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
- Where it went
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- How much
- 99
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For
Z-1340-2016 · Class II · reported 2016-04-13 · Terminated
- Why it was recalled
- The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
- Product
- Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
- Where it went
- Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
- How much
- TBD
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For
Z-1341-2016 · Class II · reported 2016-04-13 · Terminated
- Why it was recalled
- The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
- Product
- Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
- Where it went
- Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
- How much
- TBD
Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL
Z-1123-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL For use in total hip arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 2
Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-P
Z-1146-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 0
Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE CO
Z-1110-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603610 6 DEGREE COCR FEM HEAD 36 902603614 6 DEGREE COCR FEM HEAD 36 Product Usage: For use in total or hemi hip arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 209
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TU
Z-1129-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 118114502 FREE-LOCK TUBE & SCP PLAT 118114503 FREE-LOCK TUBE & SCP PLAT 118115002 FREE-LOCK TUBE & SCP PLAT 118115003 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone....
- Where it went
- US Nationwide Distribution
- How much
- 285
Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEA
Z-1127-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 0
Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 5250
Z-1150-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 925
Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4
Z-1116-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL 47248002441 CANC SCR 4.0MM X 24MM FUL 47248003641 CANC SCR 4.0MM X 36MM FUL Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Where it went
- US Nationwide Distribution
- How much
- 83
Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM C
Z-1103-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW 18MM, S 47482702001 2.7MM CORT. SCREW 20MM, S Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Where it went
- US Nationwide Distribution
- How much
- 60
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD
Z-1126-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 0
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTIO
Z-1149-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 598605702 NEXGEN OPTION STEMMED TIB for use in total knee arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 29525
Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING
Z-1134-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5 225304045 INTERLOCKING IM SCREW 4.5 225304245 INTERLOCKING IM SCREW 4.5 225304545 INTERLOCKING IM SCREW 4.5 225305045 INTERLOCKING IM SCREW 4.5 225305245 INTERLOCKING IM SCREW 4.5 225305545 INTERLOCKING IM SCREW 4.5 225305745 INTERLOCKING IM SCREW 4.5 225306045 INTERLOCKING IM SCREW 4.5 225306545 INTERLOCKING IM SCREW 4.5 225307045 INTERLOCKING IM SCREW 4.5 Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
- Where it went
- US Nationwide Distribution
- How much
- 268
Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW
Z-1115-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA 625004540 BONE SCREW 4.5X40 SELF-TA 625004550 BONE SCREW 4.5X50 SELF-TA 625006515 BONE SCREW 6.5X15 SELF-TA 625006520 BONE SCREW 6.5X20 SELF-TA 625006525 BONE SCREW 6.5X25 SELF-TA 625006530 BONE SCREW 6.5X30 SELF-TA 625006535 BONE SCREW 6.5X35 SELF-TA 625006540 BONE SCREW 6.5X40 SELF-TA 625006550 BONE SCREW 6.5X50 SELF-TA 625006560 BONE SCREW 6.5X60 SELF-TA 625006570 BONE SCREW 6.5X70 SELF-TA Product Usage: For use in total or hemi hip arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 87341
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SL
Z-1143-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST for use in total knee arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 3696
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE
Z-1132-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
- Where it went
- US Nationwide Distribution
- How much
- 512
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POL
Z-1157-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM 42540000041 PSN ALL POLY PAT PLY 41MM 42511000510 PSN ASF CR 10MM PLY L 3-1 42511000410 PSN ASF CR 10MM PLY L 3-9 42511000610 PSN ASF CR 10MM PLY L 7-1 42521000510 PSN ASF CR 10MM PLY R 3-1 42521000410 PSN ASF CR 10MM PLY R 3-9 42521000610 PSN ASF CR 10MM PLY R 7-1 42511000511 PSN ASF CR 11MM PLY L 3-1 42511000411 PSN ASF CR 11MM PLY L 3-9 42511000611 PSN ASF CR 11MM PLY L 7-1 42521000511 PSN ASF CR 11MM PLY R 3-1 42521000411 PSN ASF CR 11MM PLY R 3-9 42521000611 PSN ASF CR 11MM PLY R 7-1 42511000512 PSN ASF CR 12MM PLY L 3-1 42511000412 PSN ASF CR 12MM PLY L 3-9 42511000612 PSN ASF CR 12MM PLY L 7-1 42521000512 PSN ASF CR 12MM PLY R 3-1 42521000412 PSN ASF CR 12MM PLY R 3-9 42521000612 PSN ASF CR 12MM PLY R 7-1 42511000513 PSN ASF CR 13MM PLY L 3-1 42511000413 PSN ASF CR 13MM PLY L 3-9 42511000613 PSN ASF CR 13MM PLY L 7-1 42521000513 PSN ASF CR 13MM PLY R 3-1 42521000413 PSN ASF...
- Where it went
- US Nationwide Distribution
- How much
- 112588
Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 COR
Z-1108-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Product
- Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Where it went
- US Nationwide Distribution
- How much
- 2
Showing the 30 most recent of 91. 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