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Health Canada Medical devices

Comprehensive® Shoulder System Primary Mini Length Shouldler Stem

Issued March 13, 2025
Issue
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive® Shoulder Primary Stem (7mm Micro & 7 mm Mini). Five complaints reported that the stem implant did not fit in the inserter or that the inserter could not be detached from the stem. There were no injuries reported associated with the five complaints received. The internal investigation identified excess metal on the inner taper of the stem due to a chipped manufacturing tool. Recall start date: March 10, 2025
Hazard description
Performance
Product
Product name
Comprehensive® Shoulder System Primary Mini Length Shouldler Stem
Reference
ID
RA-77112