Reported Dec 4, 2019 · Terminated
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202…
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 Hip systems, Item Nos.
131 of 131 codes
10420710421210421511-16280911-16281011-16281111-16281211-16281321-10320221-10320321-10320421-10320521-10320621-10320721-10320821-10320921-10321021-10321121-10321221-10321521-10410921-10411021-10411121-10411221-10411321-10411421-10411521-10411621-10411721-10411821-10411921-10811021-10811221-10811521-10811721-10811921-10813021-10813221-10813521-10813721-10813921-10815021-10815221-10815521-10815721-10815921-10825121-10825321-10825521-10825721-10825921-10827121-10827321-10827521-10827721-10827921-10829121-10829321-10829521-108297
- X21-182320 X21-182321 Product UsageHip arthroplasty
- Lot codes and dates
- All lots manufactured between January 2008 - May7
4,067 of 4,067 codes
2019272750155610197670341720341750174760838240504840360250735990174770272100742290414230133510723450642570642520504830020840115890679780642620679870344370642510790050360240708170707970707980788870788880642490360270742270669070642580642600642610569050888950548290823580788860888990360260708180790060642540133500708160766460642550790070669060707960888980012620
- All lots manufactured between January 2008 - May
- 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.
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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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