Health product recall

Evolve Triad Plate Cutter

Last updated

Summary

Product
Evolve Triad Plate Cutter
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Evolve Triad Plate Cutter 2486857 1349302 1956936 955401 1168853 49510120

Issue

Stryker has identified a nonconformance relating to the Evolve Triad Plate Cutter provided in the Evolve Triad Instrument Kit (4951kit1). Specifically, the plate cutter is unable to meet sterilization requirements when it is sterilized in a double wrapped configuration according to the option 1 steam sterilization parameters detailed in Instructions for Use (IFU150824). While the surgical technique does not require use of the plate cutter, it is provided in the instrument kit so the coronoid plate can be trimmed when needed.

Recall start date: June 3, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Wright Medical Technology Inc.

1023 Cherry Road, Memphis, Tennessee, United States, 38117

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64258

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe