Reported Nov 13, 2019 · Terminated
Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287…
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?
- Various Custom Devices, Item Nos.
125 of 125 codes
328550902463285509025232855090256328550902653285509026632855090270328550902873285509029032855090291328550902973285509030232855090317328550903183285509031932855090327328550903293285509033432855090336328550903393285509034832855090351328550903523285509035332855090354328550903683285509036932855090375328550903763285509039532855090396328550904023285509040932855090414328550904343285509043732855090439328550904483285509045032855090465328550904843285509049632855090497328550904983285509050132855090507328550905123285509051932855090520328550905313285509054332855090576328550905853285509058632855090593328550905983285509059932855090609328550906153285509062232855090628
- 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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