Product Wiki · Recalls · Health Canada — Medical Devices

Sterilmed Reprocessed (Depuy Synthes, Stryker, and Smith & Nephew)… — recall 57495

Health Canada — Medical Devices · Canada · 2017-11-10 · Type III

As described by Health Canada — Medical Devices: Sterilmed Reprocessed (Depuy Synthes, Stryker, and Smith & Nephew) External Fixation Systems (2017-10-18)

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Agency
Health Canada — Medical Devices
Recall identifier
57495
Date of alert
2017-11-10
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Sterilmed has initiated a medical device correction for all lots of listed Sterilmed reprocessed DePuy Synthes, Stryker, and Smith & Nephew external fixation systems. Sterilmed has discovered the product label and IFU do not contain information regarding the safety and compatibility of the subject products in a magnetic resonance environment and such labeling is inconsistent with the OEM labeling.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sterilmed-reprocessed-depuy-sy

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