Reported Mar 21, 2018 · Terminated

NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3…

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?

NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

Lot codes and dates: 92 of 92 codes
6307-00-008
62125578
6307-00-020
61975784
6307-00-020
62098206
6307-00-030
11004845
6307-00-030
62142198
6307-00-009
62107229
6307-00-021
11004878
6307-00-021
62160819
6307-00-021
62155319
6307-00-021
62162357
6307-00-021
62164084
6307-00-021
62176798
6307-00-021
62174770
6307-00-021
62173770
6307-00-021
62177132
6307-00-021
62172373
6307-00-021
62178184
6307-00-021
62178731
6307-00-021
62183228
6307-00-021
62180483
6307-00-021
62185696
6307-00-021
62181538
6307-00-021
62188142
6307-00-021
11007719
6307-00-021
62189950
6307-00-021
62193587
6307-00-021
62190389
6307-00-021
62192798
6307-00-021
62196210
6307-00-021
62194526
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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By hazard

Medical device recalls

Other recalls from Zimmer Biomet, Inc.

84 in total.

All recall categories · Browse the whole archive