Product Wiki · Recalls · Health Canada — Medical Devices

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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Agency
Health Canada — Medical Devices
Recall identifier
55186
Date of alert
2016-07-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/smith-nephew-inc-hip-replaceme

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