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Health Canada Medical devices

Monterey AL AL Implant Inserter

Issued March 10, 2025
Issue
For the lots in scope of this assessment, there has been a trend of reports from the field that found there was the potential for the gold unlock button to separate from the inserter. Investigation determined that this is due to potential tolerance interference within the design that can lead to the pin not being flush, causing weld penetration to not meet specification and the gold unlock button to separate from the inserter. Recall Start Date: February 27, 2025
Hazard description
Performance
Product
Product name
Monterey AL AL Implant Inserter
Reference
ID
RA-77086