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Tps system - elite burs

Official notice

27 Jun 2022

Last checked

27 Jun 2022

Critical riskHealth Canada

An official Health Canada notice concerns Tps system - elite burs. During internal product/process review (April 2022), it was discovered that there is a potential for the core diameter to be undersized, which may lead to the router breaking. To date, Stryker has not been made aware of any adverse events related to this issue. Recall start date: June 16, 2022 Published 2022-06-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64316

Official notice

2022-06-27

The hazard

During internal product/process review (April 2022), it was discovered that there is a potential for the core diameter to be undersized, which may lead to the router breaking. To date, Stryker has not been made aware of any adverse events related to this issue. Recall start date: June 16, 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

64316

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Affected products

Product 1

Affected products - Tps System - Elite Burs, Lot or serial number - 20140017 21330017 22011017 20216017 20139027, Model or catalogue number - 5820-071-023

Risk / hazard

During internal product/process review (April 2022), it was discovered that there is a potential for the core diameter to be undersized, which may lead to the router breaking. To date, Stryker has not been made aware of any adverse events related to this issue. Recall start date: June 16, 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: Stryker Instruments A Division Of Stryker, Tps System - Elite Burs.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

64316

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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