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No image published for this recall

Triathlon system

Official notice

14 Mar 2022

Last checked

14 Mar 2022

Medium riskHealth Canada

An official Health Canada notice concerns Triathlon system. 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 Published 2022-03-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63993

Official notice

2022-03-14

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63993

Lots

/or

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Affected products

Product 1

Affected Products - Triathlon Tritanium Tibial Component, Lot or Serial Number - CTD68500, Model or catalog number - 5536-B-200

Product 2

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Howmedica Osteonics, Triathlon System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63993

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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