Reported Nov 13, 2019 · Terminated
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817…
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?
- Trabecular Metal Reverse Shoulder System, Item Nos.
68 of 68 codes
004342106130043090010300434210613004342108130043421081700434210913004342110130043421101700434211113004342112130043421121700434211313004342114130043421141700434211513004342116130043421171300434211813004348106130043481081300434810817004348109130043481101300434811017004348111130043481121300434811217004348113130043481141300434811417004348115130043481161300434811713004348118130043490081300434900817004349010130043490101700434901213004349012170043490141300434903700004349038110043490390900434903912328550903393285509035332855090368328550903753285509039532855090512328550905193285509052032855090531328550905853285509059332855090598328550905993285509062832855090636
- 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.
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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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