FDA-Device2016-03-02Class II
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 a
Zimmer Biomet, Inc.
Hazard
LDPE bag containing the implant adheres to the highly polished implant surface.
Sold states
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
Affected count
72806
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
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."
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2016Don't want to check this manually?
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