Zimmer GmbH

Zimmer GmbH: 99 FDA recall reports

Every medical device recall the FDA has published for Zimmer GmbH. The fault, and how the agency graded it.

99Reports
0Class I
2Ongoing
2024-09-18Most 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.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt 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

ClassReports
Class II99

By year reported

YearReports
20157
20166
20171
20184
201977
20212
20242
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.

Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented

Z-3133-2024  ·  Class II  ·  reported 2024-09-18  ·  Ongoing

Why it was recalled
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Product
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
Where it went
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
How much
58 units

Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with ceme

Z-3132-2024  ·  Class II  ·  reported 2024-09-18  ·  Ongoing

Why it was recalled
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Product
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Where it went
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
How much
69 units

Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended

Z-1792-2021  ·  Class II  ·  reported 2021-06-09  ·  Terminated

Why it was recalled
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Product
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
Where it went
CA, GA, KY, MD Foreign: Australia Brazil, Canada Netherlands
How much
8 units

Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intende

Z-1793-2021  ·  Class II  ·  reported 2021-06-09  ·  Terminated

Why it was recalled
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Product
Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
Where it went
CA, GA, KY, MD Foreign: Australia Brazil, Canada Netherlands
How much
16 units

Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The

Z-2762-2019  ·  Class II  ·  reported 2019-10-09  ·  Terminated

Why it was recalled
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Product
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
Where it went
Worldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.
How much
19 unit worldwide

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637

Z-1448-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, contra-angle, 1.5x85mm, Item Number ST502015706

Z-1486-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, contra-angle, 1.5x85mm, Item Number ST502015706
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 3x90mm, AO, Item Number ST502015631

Z-1482-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 3x90mm, AO, Item Number ST502015631
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

Z-1455-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114

Z-1415-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 2.5x95mm, AO, Item Number 502015621

Z-1439-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216

Z-1472-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 2.8x150mm, AO, Item Number 502015629

Z-1442-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638

Z-1449-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 3x90mm, round shaft, Item Number 502015630

Z-1443-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 3x90mm, round shaft, Item Number 502015630
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352

Z-1458-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628

Z-1480-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 4x120mm, AO, Item Number ST502015402

Z-1474-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 4x120mm, AO, Item Number ST502015402
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212

Z-1430-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120

Z-1417-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

CBS 7.5 tap, cannulated, AO, Item Number 503002041

Z-1453-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
CBS 7.5 tap, cannulated, AO, Item Number 503002041
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207

Z-1469-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216

Z-1432-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145

Z-1424-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

V-TEK", Micro-countersink, AO, Item Number 28.66.113

Z-1465-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
V-TEK", Micro-countersink, AO, Item Number 28.66.113
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 2x95mm, round shaft, Item Number 502015619

Z-1437-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 2x95mm, round shaft, Item Number 502015619
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

CBS high, countersink, cannulated, round-shaft, Item Number 503004342

Z-1456-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
CBS high, countersink, cannulated, round-shaft, Item Number 503004342
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 2.8x120mm, AO, Item Number 502015628

Z-1441-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 2.8x120mm, AO, Item Number 502015628
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, 2.5x135mm, AO, Item Number 502015142

Z-1423-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, 2.5x135mm, AO, Item Number 502015142
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640

Z-1484-2019  ·  Class II  ·  reported 2019-05-29  ·  Terminated

Why it was recalled
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product
Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640
Where it went
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
How much
N/A

Showing the 30 most recent of 99. 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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