Product Wiki · Recalls · Health Canada — Medical Devices

Comprehensive Segmental Revision System (SRS)/Discovery Distal Body… — recall 60775

Health Canada — Medical Devices · Canada · 2018-03-23 · Type II

As described by Health Canada — Medical Devices: Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm (2018-03-13)

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Agency
Health Canada — Medical Devices
Recall identifier
60775
Date of alert
2018-03-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Zimmer Biomet is conducting a recall of specific lots of the comprehensive Segmental Revision System (SRS)/discovery distal body with screw. Zimmer Biomet has received reports that during assembly, an SRS humeral distal body implant failed to engage correctly at the point of reduction with a discovery elbow system humeral condyle. A mismatch occurred between the screw holes in the distal humeral body and the discovery elbow condyle implant during vendor machine operation. The mismatch does not always prevent engagement of the screw and the condition would be noticed during assembly.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/comprehensive-segmental-revisi

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