Reported Mar 21, 2018 · Terminated
fastener, fixation, nondegradable, soft tissue
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- fastener, fixation, nondegradable, soft tissue
- Lot codes and dates
- Item # 110019010 Lot #'s
017350141990142000142020167190240720240740240770257970398710398730398740398750421780421790421800465910504120813190940370
- Item # 110019010 Lot #'s
- Amount recalled
- 429 units
This recall covers 59 products
The agency filed one notice per product. You are reading one of them; the other 58 are below.
46 more are in the archive.
Where it was sold
Why it was recalled
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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