Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long
Brand(s)
Last updated
Summary
Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long
Issue
Medical devices - Increased risk or new adverse events
What to do
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long |
396250 |
113635 |
Issue
Zimmer Biomet is conducting a lot specific medical device recall for the comprehensive shoulder system mini humeral stem. The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength, which could potentially lead to the risks identified.
Recall start date: Jan 12, 2022
Additional information
Details
Original published date: 2022-01-20
Alert / recall type
Health product recall
Category
Health product - Medical device - Orthopaedics
Companies
| Biomet Orthopedics |
|
56 East Bell Drive, Warsaw, Indiana United States, 46581 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63829