Recall MonitorHealth Products
Comprehensive® Shoulder System Primary Mini Length Shouldler Stem
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
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
Recall class: Type II
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