Reported Nov 13, 2019 · Terminated
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817…
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?
- BF Humeral Stem, Various Sizes, Item Nos.
004300006060043000061300430000706004300007130043000081300430000817004300008200043000091300430001013004300010170043000102000430001113004300012130043000121700430001220004300013130043000141300430001417004300014200043000151300430001613004300017130043000181347430103100
- Lot codes and dates
- All product manufactured prior to January 2014.
- Amount recalled
- 5,459,583 total devices
This recall covers 41 products
The agency filed one notice per product. You are reading one of them; the other 40 are below.
28 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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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