Comprehensive® Shoulder System Primary Mini Length Shouldler Stem
Brand(s)
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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