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Health Canada Medical devices

Howmedica Revision Instrument System (HRIS) Storage & Sterilization Case and Tray

Issued June 6, 2024
Issue
Gray revision instruments are single-use, sterile-packaged manual surgical instruments intended for one-time use during hip or knee arthroplasty, or trauma surgeries. The HRIS storage & sterilization case and tray part number 6210-9-900 has dedicated locations that include instrument silhouettes and part number markings that are silkscreen printed on the trays for the instruments. This may lead to the re-use and re-sterilization of these single-use sterile-packaged instruments. Recall Start Date: May 23, 2024
Hazard description
Sterility
Product
Product name
Howmedica Revision Instrument System (HRIS) Storage & Sterilization Case and Tray
Reference
ID
RA-75629