Product Wiki · Recalls · Health Canada — Medical Devices

Biolox Forte 36mm Alumina Ceramic Femoral Heads — recall 56285

Health Canada — Medical Devices · Canada · 2017-03-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56285
Date of alert
2017-03-10
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: It was found during Microport's Investigation that the Biolox Forte 36mm Alumina Ceramic Head was confirmed to measure approximately 2mm shorter than other Microport 36mm Femoral Heads (Cobalt Chrome and Biolox Delta Ceramic Femoral Heads). The ultimate hazard would be joint laxity and/or dislocation, which could result in revision surgery.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/biolox-forte-36mm-alumina-cera

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