Reported Mar 21, 2018 · Terminated
VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
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. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
- Lot codes and dates
- Item Number00-7843-015-11
- Lot Numbers62097294 11006832 62116495 61981821
- Item Number00-7843-015-12
- Lot Numbers
6208529411004177620972446175925962133149618070977700082161963730
- Amount recalled
- 13,227 in total
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
- Nationwide
Why it was recalled
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
This product could cause temporary or reversible health problems — stop using it.
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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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