Reported Mar 21, 2018 · Terminated
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT…
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?
- GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
- Lot codes and dates
1,106 of 1,106 codes
00-5412-015-026177775600-5412-015-021100314900-5412-015-026178297700-5412-015-026179604700-5412-015-026180656300-5412-015-026180656200-5412-015-026186721200-5412-015-026186721300-5412-015-026187203500-5412-015-026187142400-5412-015-021100442200-5412-015-021100447700-5412-015-026187622600-5412-015-026188524000-5412-015-026188937000-5412-015-026189443600-5412-015-026189951100-5412-015-021100144000-5412-015-026190415400-5412-015-026191602900-5412-015-026192136100-5412-015-026192867700-5412-015-026194020700-5412-015-026195263500-5412-015-026196380700-5412-015-026196894800-5412-015-026198810600-5412-015-021100584000-5412-015-026198353600-5412-015-0261975655
- 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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