Reported Mar 2, 2016 · Terminated
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes…
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?
- ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes 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
- Item numbers
00-5842-011-0100-5842-011-0200-5842-012-0100-5842-012-0200-5842-013-0100-5842-013-0200-5842-014-0100-5842-014-0200-5842-015-0100-5842-015-0200-5842-016-0100-5842-016-0200-5842-017-0100-5842-017-02
- Lot numbers
1,577 of 1,577 codes
110025041100276411002766110027671100278011002782110027841100300911003028110030421100304811003345110033661100336711003370110033711100338411003398110033991100341311003414110034331100345211003488110034901100349111003584110035871100358811003589110036031100361111003635110036421100364911003658110036591100366011003661110036891100385511003868110038781100390411003921110039441100395911003960110039741100405211004056110040741100414611004150110041521100416111004204110043061100433511004401
- Item numbers
- Amount recalled
- 32537
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- FL
Why it was recalled
LDPE bag containing the implant adheres to the highly polished implant surface.
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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