Reported Mar 2, 2016 · Terminated
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various…
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?
- Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the
- MultiPolar Bipolar Cup is indicated inFracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is contraindicated. Irreducible fractures in which adequate fixation cannot be obtained. Certain high subcapital fractures and comminuted femoral neck fractures in the aged. Nonunion of femoral neck fractures. Secondary avascular necrosis of the femoral head. Pathological fractures of the femoral neck. Osteoarthritis in which the femoral head is primarily affected."
- Lot codes and dates
- Item numbers
00-5001-038-0000-5001-039-0000-5001-040-0000-5001-041-0000-5001-042-0000-5001-043-0000-5001-044-0000-5001-045-0000-5001-046-0000-5001-047-0000-5001-048-0000-5001-049-0000-5001-050-0000-5001-051-0000-5001-052-0000-5001-053-0000-5001-054-0000-5001-055-0000-5001-057-0000-5001-058-0000-5001-060-0000-5001-062-0000-5001-064-0000-5001-066-0000-5001-068-0000-5001-070-0000-5001-072-00
- Lot numbers
3,101 of 3,101 codes
003701740037017600370178003701810037045300370454003704550037045700370461003706650037075100370810003708580037085900370860003708660037086700370868003708690037087000370871003708750037089300370894003708950037090800370909003709100037091100370912003709200037092400370925003709450037094600370947003709480037094900370950003709510037095200370953003709540037098600370988617620246177492361774933617792946178377461783798617838016178688361786899617869016178690261786903617869046178690561786906
- Item numbers
- Amount recalled
- 72806
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- FL
Why it was recalled
LDPE bag containing the implant adheres to the highly polished implant surface.
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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