Reported Mar 21, 2018 · Terminated
ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM…
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?
- ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM SZD RMED/LLAT¿ ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLAT " These
- devices are indicated for patients with- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees
- Lot codes and dates
00-5842-012-026177760600-5842-012-026177409300-5842-013-016177409500-5842-013-026177761100-5842-014-011100292100-5842-014-016177761300-5842-014-026177761500-5842-014-026177761600-5842-015-016177761700-5842-016-0261756843
- 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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