Reported Apr 26, 2017 · Terminated

various polyethylene implants Custom parts Product Usage: Custom

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. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • various polyethylene
  • implants Custom parts Product UsageCustom
Lot codes and dates

38 of 38 products

Products covered by this recall
Model / numberProduct as published
110010452732130 920720
110010454136510
110010455752320 896040
110010456383320 879930
110010459854290 879950 905350
110010462752460 778490
110010468827730
110010476827530 827540
110010716753050
CP753453655990
CP753455656110
CP753461382210
CP753470436530
CP753476502920
CP753478524950
CP753480436460
CP753486655300
CP753488655470
CP753494467390
CP753496467420
Amount recalled
28,253 in total

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

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 Jan 29, 2018 · Data as of Sep 19, 5:27 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.