Health product recall

Comprehensive® Shoulder System Primary Mini Length Shouldler Stem

Last updated

Summary

Product
Comprehensive® Shoulder System Primary Mini Length Shouldler Stem
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Comprehensive® Shoulder System Primary Mini Length Shouldler Stem

65915809
65909480
65901697

113627

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Biomet Orthopedics

56 East Bell Drive, Warsaw, Indiana, United States, 46581

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77112

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