Reported Nov 13, 2019 · Terminated
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535…
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?
- Various fixation systems and accessories, Item Nos.
304 of 304 codes
001181005220011810052700118100530001181005320011810053500118100537001181005400011810054200118100550001181005520011810056200118100565001181005670011810102200118101025001181010270011810103000118101032001181010350011810103700118101040001181010420011810104500118101047001181010500011810105200118101055001181010570011810106000118101522001181015250011810152700118101530001181015320011810154700118101552001181015570011810900600118109008001181090100011810950600118109510001181130020011811300300118113004001181130050011811300600118113008001181130100011811301200118113094001181135020011811350300118113504001181135050011811350600118113508001181135100011811351200118113514
- Lot codes and dates
- All products manufactured prior to January 2014.
- Amount recalled
- 5,459,583 total devices
This recall covers 41 products
The agency filed one notice per product. You are reading one of them; the other 40 are below.
28 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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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