Reported Nov 13, 2019 · Terminated
Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106…
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?
- Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos.
0100551102010055110301005511040100551105010055110601005511070100551108010055110901005511100100551111010055111201005511130100551114010055120101005512020100551203010055120401005512050100551206010055120701005512080100551209010055121001005512110100551212010055121301005512140100551301010055130201005513030100551304010055130501005513060100551307010055130801005513090100551310010055131101005513120100551313010055131401005514010100551402010055140301005514040100551405010055140601005514070100551408010055140901005514100100551411010055141201005514130100551414
- 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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