Reported Dec 4, 2019 · Terminated
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645…
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?
- Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos.
11-11464111-11464211-11464311-11464411-114644S11-11464511-11464611-11464711-11464811-11466111-11466211-11466311-11466411-114664S11-11466511-11466611-11466711-11466811-11463211-114633
- Product UsagePartial Shoulder Replacement
- Lot codes and dates
- All lots manufactured
- between January 2008 - May 2019
2,317 of 2,317 codes
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- Amount recalled
- 219988 units (total)
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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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