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."
FDA Recall Z-0845-2016 · Posted 2016-02-22
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeKWY
Date Initiated2016-01-11
Date Terminated2017-05-23
Product Quantity72806
Reason for Recall
LDPE bag containing the implant adheres to the highly polished implant surface.
Firm Action
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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