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Health Canada Medical devices

Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures

Issued January 31, 2024
Issue
Specific lots of the Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. The affected lots were distributed between May 2022 and November 2023. The extra gamma levels or additional EO cycle have the potential to decrease the strength of these sutures over time. Recall Start Date: January 25, 2024
Hazard description
Performance
Product
Product name
Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures
Reference
ID
RA-74963