Health product recall

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long

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