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Zimmer Biomet, Inc. recalls Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various siz
Recalled March 2, 2016 · FDA recall Z-0845-2016 · Zimmer Biomet
Hazard
LDPE bag containing the implant adheres to the highly polished implant surface. · FDA Class II
Units
72806
Sold at
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
Description
LDPE bag containing the implant adheres to the highly polished implant surface.
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."
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →