FDAClass IIApril 9, 2025

Monterey AL Implant Inserter recall

Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.

Why was Monterey AL Implant Inserter recalled?

Potential for the gold unlock button to separate from the inserter.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog 48019130; UDI-DI: 07613327501049; Lot Number: 231639;

Product
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Recalling firm
Stryker Spine
Quantity
46 units (44 US, 2 OUS)
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Recall date
April 9, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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