Recall Monitor
Health Products

Monterey AL AL Implant Inserter

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Monterey AL AL Implant Inserter
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Monterey AL AL Implant Inserter231639
231638
231640
231634		48019140
48019130
48019100
48019120

Issue

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

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