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Health Canada Medical devices

8mm, Tip-Up Fenestrated Grasper, IS4000

Issued June 20, 2023
Issue
The tip-up fenestrated grasper has two versions on the approved product list (APL): 470347-11 and 470347-12. PN 470347-11 uses machined grips, while PN 470347-12 uses grips that have been manufactured via metal-injection molding (MIM). There have been complaints reported for a broken grip issue against the MIM grips. Grip breakage is observed on both upper and/or lower grips. Recall start date: June 8, 2023
Hazard description
Performance
Product
Product name
8mm, Tip-Up Fenestrated Grasper, IS40
Reference
ID
RA-73855