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Monterey al al implant inserter

Official notice

10 Mar 2025

Last checked

10 Mar 2025

Critical riskHealth Canada

An official Health Canada notice concerns Monterey al al implant inserter. For the lots in scope of this assessment, there has been a trend of reports from the field that found there was the potential for the gold unlock button to separate from the inserter. Investigation determined that this is due to potential tolerance interference within the design that can lead to the pin not being flush, causing weld penetration to not meet specification and the gold unlock button to separate from the inserter. Recall Start Date: February 27, 2025 Published 2025-03-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77086

Official notice

2025-03-10

The hazard

For the lots in scope of this assessment, there has been a trend of reports from the field that found there was the potential for the gold unlock button to separate from the inserter. Investigation determined that this is due to potential tolerance interference within the design that can lead to the pin not being flush, causing weld penetration to not meet specification and the gold unlock button to separate from the inserter. Recall Start Date: February 27, 2025

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

77086

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Affected products

Product 1

Affected products - Monterey AL AL Implant Inserter, Lot or serial number - 231639 231638 231640 231634, Model or catalog number - 48019140 48019130 48019100 48019120

Risk / hazard

For the lots in scope of this assessment, there has been a trend of reports from the field that found there was the potential for the gold unlock button to separate from the inserter. Investigation determined that this is due to potential tolerance interference within the design that can lead to the pin not being flush, causing weld penetration to not meet specification and the gold unlock button to separate from the inserter. Recall Start Date: February 27, 2025

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 Spine, Monterey Al Al Implant Inserter.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

77086

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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