Bipolar Shell prosthesis — Class II medical device recall Z-0845-2016

Terminated recall by Zimmer Biomet, Inc., reported 2016-03-02, distributed nationwide. LDPE bag containing the implant adheres to the highly polished implant surface.

Recall number	`Z-0845-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Zimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated	2016-01-11
Classified	2016-02-22
Reported by FDA	2016-03-02
Terminated	2017-05-23
Distributed	Nationwide (US)
Countries outside the US	AR, AT, AU, BB, BE, BM, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, ES, FR, GB, GT, HK, HN, HR, IL, IN, IT, JM, JP, KR, MX, MY, NI, NZ, PA, PE, SE, SG, SV, TH, TW, VE
Quantity	72,806
Lot numbers	`00370174`, `00370176`, `00370178`, `00370181`, `00370453`, `00370454`, `00370455`, `00370457`, `00370461`, `00370665`, `00370751`, `00370810`, `00370858`, `00370859`, `00370860`, `00370866`, `00370867`, `00370868`, `00370869`, `00370870`, `00370871`, `00370875`, `00370893`, `00370894`, `00370895`, `00370908`, `00370909`, `00370910`, `00370911`, `00370912`, `00370920`, `00370924`, `00370925`, `00370945`, `00370946`, `00370947`, `00370948`, `00370949`, `00370950`, `00370951` and 460 more
Model numbers	`00-5001-038-00`, `00-5001-039-00`, `00-5001-040-00`, `00-5001-041-00`, `00-5001-042-00`, `00-5001-043-00`, `00-5001-044-00`, `00-5001-045-00`, `00-5001-046-00`, `00-5001-047-00`, `00-5001-048-00`, `00-5001-049-00`, `00-5001-050-00`, `00-5001-051-00`, `00-5001-052-00`, `00-5001-053-00`, `00-5001-054-00`, `00-5001-055-00`, `00-5001-057-00`, `00-5001-058-00`, `00-5001-060-00`, `00-5001-062-00`, `00-5001-064-00`, `00-5001-066-00`, `00-5001-068-00` and 2 more

Product

Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture 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."

Reason for recall

LDPE bag containing the implant adheres to the highly polished implant surface.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0845-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.