Product Wiki · Recalls · Health Canada — Medical Devices

Star Total Ankle Replacement - Sliding Core (2019-10-24) — recall 44582

Health Canada — Medical Devices · Canada · 2019-11-08 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44582
Date of alert
2019-11-08
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Stryker has become aware of data indicating that patients implanted with the Star Total Ankle Replacement distributed prior to August 1, 2014 may experience a higher than expected risk of polyethylene fracture due to potential increase in polyethylene oxidation prior to or after implantation and potentially the implant geometry (as reported in published literature).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/star-total-ankle-replacement-s

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