Stryker Spine 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 models with a 10/12mm size and catalog number 48019100 because the gold unlock button might separate. This could cause the device to malfunction during spinal surgery, posing a risk to patients.

Why it’s dangerous

The gold unlock button may detach from the inserter during use, potentially causing the device to malfunction. This could lead to improper spinal implant placement or other surgical complications.

Who’s affected

Surgical teams using the Monterey AL Implant Inserter for spinal procedures are most at risk. Patients undergoing surgery with this device could be affected if the button separates.

How to tell if you have this one

Check for the catalog number 48019100 on the device. Units sold with UDI-DI: 07613327456462 and lot number 231634 are affected.

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 48019100, UDI-DI: 07613327456462, and lot number 231634 on the Monterey AL Implant Inserter.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The recall is due to the potential for the gold unlock button to separate from the inserter, which could cause malfunction during spinal surgery.

How can I tell if my device is affected?

Check for catalog number 48019100, UDI-DI: 07613327456462, and lot number 231634 on the device.

What should I do if I have this device?

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

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-1488-2025 — Stryker Spine Stryker Spine

Hello,

I own a Stryker Spine that is covered by recall Z-1488-2025 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-1488-2025 (February 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1488-2025 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; 10/12mm; Catalog 48019100.

Use caution until it’s fixed