thejoe Nobel Biocare Usa Llc

Nobel Biocare Usa Llc: 66 FDA recall reports

Every medical device recall the FDA has published for Nobel Biocare Usa Llc. The fault, and how the agency graded it.

66Reports

0Class I

0Ongoing

2022-03-02Most 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	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

Class	Reports
Class II	66

By year reported

Year	Reports
2013	1
2015	28
2016	2
2018	1
2020	33
2022	1

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.

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Z-0658-2022 · Class II · reported 2022-03-02 · Terminated

Why it was recalled: Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Product: NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Where it went: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
How much: 702 pieces

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)073327

Z-2207-2020 · Class II · reported 2020-06-10 · Terminated

Why it was recalled: The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
Product: NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Where it went: US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None
How much: 221 implants

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental im

Z-2250-2020 · Class II · reported 2020-06-10 · Terminated

Why it was recalled: Packaged dental implant healing abutments were found to contain the wrong size device.
Product: Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
How much: 234 pieces globally, of which 16 were sent to the US.

Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous imp

Z-1854-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Product: Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
How much: 227 pieces

Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous

Z-1853-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Product: Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
How much: 239

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441

Z-1851-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
Product: NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Where it went: International distribution - the country Russia only.
How much: 228 pieces

Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implant

Z-1856-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Product: Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
How much: 238 pieces

Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to th

Z-1857-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Product: Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
How much: 478 pieces

Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosse

Z-1852-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Product: Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
How much: 236

Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous im

Z-1855-2020 · Class II · reported 2020-05-13 · Terminated

Why it was recalled: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Product: Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it went: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
How much: 215 pieces

Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tape

Z-1302-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: None

Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapere

Z-1307-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 473 units

Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapere

Z-1309-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 260 units

Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower

Z-1315-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: None

Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw

Z-1311-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 264 units

Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills

Z-1305-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: None

Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can b

Z-1322-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 233 units

Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but includ

Z-1324-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 7 units

Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered

Z-1306-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered

Z-1304-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 8 units

Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered D

Z-1303-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 8 units

Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if

Z-1317-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 197 units

Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower j

Z-1312-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 59 units

Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw

Z-1313-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: None

Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lowe

Z-1314-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: None

Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if

Z-1319-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 423 units

Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant

Z-1318-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 31 units

Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants

Z-1320-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 526 units

Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered

Z-1308-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 346 units

Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if

Z-1316-2020 · Class II · reported 2020-02-26 · Terminated

Why it was recalled: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Product: Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Where it went: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
How much: 2470 units

Showing the 30 most recent of 66. 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.

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