Product Wiki · Recalls · Health Canada — Medical Devices

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15… — recall 63829

Health Canada — Medical Devices · Canada · 2022-01-17 · Type II

As described by Health Canada — Medical Devices: Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
63829
Date of alert
2022-01-17
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Orthopaedics
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/comprehensive-shoulder-system-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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