Reported Mar 21, 2018 · Terminated
VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM…
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 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Lot codes and dates
20 of 20 products
Products covered by this recall Model / number Product as published 00-7843-012-08— — Lot Numbers: 62053685 62116471 00-7843-013-08— — Lot Number: 62184774 00-7843-014-08— — Lot Numbers: 62184777 62158847 62184778 00-7843-013-81— — Lot Numbers: 61987954 61815082 62116484 61956726 00-7843-015-08— — Lot Number: 62158851 00-7843-013-82— — Lot Numbers: 61937673 61759258 61951276 61815083 62120674 61829373 77000819 00-7843-015-81— — Lot Numbers: 61968101 61781981 61968103 00-7843-015-82— — Lot Numbers: 61834826 61932605 00-7843-016-81— — Lot Numbers: 61735809 61759260 00-7843-016-82— — Lot Numbers: 62029071 61775246 62029071N 61981820 77000820 - 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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