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Health Canada Medical devices

Aequalis® Flex Revive® Assembly Screw

Issued June 21, 2023
Issue
Stryker has identified a nonconformance in a specific lot of Aequalis® Flex Revive® Assembly Screws. Specifically, a comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis® Flex Revive® Assembly Screws 0mm standard (ARS655101) but it was a Aequalis® Flex Revive® Assembly Screw 0mm short (ARS655118) & vice versa. Recall start date : June 7, 2023
Hazard description
Labelling and packaging
Product
Product name
Aequalis® Flex Revive® Assembly Screw
Reference
ID
RA-73861