Smith & Nephew, Inc. Hip Replacement Parts - Part I (2016-06-24) — recall 55186
Health Canada — Medical Devices · Canada · 2016-07-20 · Type II
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Reported risk: Smith & Nephew, Inc. has initiated a voluntary field safety corrective action/recall of the ceramic hip prostheses. The current hip prostheses IFUs do not provide adequate instruction on the revision surgeries due to ceramic failure. The IFU does not provide the detailed instructions that if a hip prostheses revision is required due to a fractured ceramic component, revisions shall only be performed using a ceramic femoral ball head in order to prevent any potential undue wear of the revision components.
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