CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report

Monterey AL Implant Inserter recalled by Stryker Spine

Stryker Spine is recalling Monterey AL Implant Inserter, distributed in 13 states. The recall was initiated on 28 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 48019130; UDI-DI: 07613327501049; Lot Number: 231639;

Quantity recalled46 units (44 US, 2 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1490-2025
FDA event ID: 96349
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2025
FDA classified: 31 Mar 2025
Reported: 9 Apr 2025
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Feb 2025	Recall initiated by company
31 Mar 2025	Classified by FDA	+31 days
9 Apr 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.

California Colorado Florida Georgia Illinois Massachusetts Nebraska New Hampshire New York Oklahoma Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 96349

This product is part of a recall event; the main page for the event is Monterey AL Implant Inserter recalled by Stryker Spine.

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
9 Apr 2025	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
9 Apr 2025	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states

More recalls from Stryker Spine

All 29

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025Device	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
9 Apr 2025Device	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
9 Apr 2025Device	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
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