Reported Nov 6, 2013 · Terminated

CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1…

Zimmer, 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, Inc. · 345 E Main St · Warsaw, IN · 46580-2746

Is this the product you have?

24 of 24 products

Products covered by this recall
#Product as published
1CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR
2CPT 12/14 SIZE 0 COCR EXT
3CPT 12/14 STEM SIZE 1 COCR
4CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR
5CPT 12/14 SIZE 2 COCR EXT
6CPT 12/14 SIZE 2 COCR 180MM
7CPT 12/14 SIZE2 COCR XEXT
8CPT 12/14 STEM SIZE 3 COCR
9CPT 12/14 SIZE 3 COCR EXT
10CPT 12/14 SZ 3 COCR 180MM EXT
11CPT 12/14 SIZE 3 COCR XEXT
12CPT 12/14 STEM SIZE 4 COCR
13CPT 12/14 SIZE 4 COCR EXT
14CPT 12/14 SIZE 4 COCR EXT
15CPT 12/14 SZ 4 COCR 230MM EXT
16CPT 12/14 SZ 4 COCR 260MM EXT
17CPT 12/14 SIZE 4 COCR XEXT
18CPT 12/14 STEM SIZE 5 COCR
19CPT 12/14 SIZE 5 COCR EXT
20CPT 12/14 SIZE 5 COCR XEXT
Lot codes and dates
  • Part Number Range00-8114-000/050-00/30
Amount recalled
24561

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

  • Nationwide

Why it was recalled

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 25, 2014 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.