Stry: Monterey AL Implant Inserter Recall - Gold Button May Separate

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Recalling firmStryker Spine59 State Rt 17 S · Allendale, NJ 07401-1614

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker Spine is recalling Monterey AL Implant Inserter devices (22mm, Catalog 48019140) because the gold unlock button might separate. This could lead to improper use during spinal surgery procedures.

Why it’s dangerous

The gold unlock button may separate from the inserter during use, potentially causing improper device function. This could lead to incorrect spinal implant placement if the button fails to engage properly.

Who’s affected

Healthcare professionals using the Monterey AL Implant Inserter for spinal surgery are most at risk. Patients are not directly affected by this recall.

How to tell if you have this one

Check for the Monterey AL Implant Inserter (22mm) with Catalog number 48019140. Units also have UDI-DI: 07613327501124 and Lot Number 231640.

Brand
Stryker Spine
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Identifiers
Look for Catalog number 48019140, UDI-DI: 07613327501124, and Lot Number 231640 on the device.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall indicates a potential issue with the gold unlock button separating, but the device is still safe for use unless the button separates.

How can I confirm if my device is affected?

Check for Catalog number 48019140, UDI-DI: 07613327501124, and Lot Number 231640 on the device.

What should I do if I have this device?

The recall does not specify a remedy, so contact Stryker Spine directly for guidance.

Take action

Contact Stryker Spine

We’ve drafted a message you can send Stryker Spine to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1491-2025 — Stryker Spine Stryker Spine

Hello,

I own a Stryker Spine that is covered by recall Z-1491-2025 from Stryker Spine.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1491-2025 (February 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1491-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Stryker Spine recalls Monterey AL Implant Inserter; 22mm; Catalog 48019140.

Lower-risk recall