Health product recall

Triathlon System

Last updated

Summary

Product
Triathlon System
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Triathlon Tritanium Tibial Component CTD68500 5536-B-200
Triathlon Total Knee System - Primary Cemented Tibial Baseplate JA44S, JAL2Y 5520-B-700, 5520-B-500

Issue

Stryker has discovered (via complaint trending initiated February 2022) that any one of the following product markings on the Triathlon® primary and Tritanium tibial baseplates listed above may be incorrect: catalog number, lot number, and/or size (2 through 7). As a result, the product markings on the part may not match the catalog number, lot number, and/or size on the corresponding package and patient label. Although the product marking on the devices may be incorrect, the device within the packaging matches the actual size that is on the corresponding package and patient labels.

Recall start date: Mar 7, 2022

Additional information

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

Howmedica Osteonics Corporation

325 Corporate Drive, Mahwah, New Jersey

United States, 07430

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63993

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