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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Monterey AL Implant Inserters Recalled for Component Separation Risk

Agency Publication Date: March 31, 2025
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Summary

Stryker Spine is recalling 210 Monterey AL Implant Inserters because a gold unlock button may separate from the tool. These surgical instruments are used by surgeons during spinal procedures to hold and place implants. If the button detaches during surgery, it could lead to surgical delays or potentially fall into the patient's surgical site. No injuries or incidents have been reported at this time.

Risk

The gold unlock button on the inserter can detach, which may cause the device to fail during a procedure or result in a component falling into the surgical opening, requiring additional surgical steps to retrieve it.

What You Should Do

  1. This recall affects Monterey AL Implant Inserters in sizes 10/12mm, 14/16mm, 18/20mm, and 22mm with catalog numbers 48019100, 48019120, 48019130, and 48019140.
  2. Check your surgical inventory for lot numbers 231634, 231638, 231639, and 231640.
  3. Stop using the recalled device immediately.
  4. Contact Stryker Spine or your medical distributor to arrange for the return, replacement, or correction of the inserters.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Monterey AL Implant Inserter (10/12mm)
Variants: 10/12mm
Model / REF:
48019100
Lot Numbers:
231634
UDI:
07613327456462

Recall #: Z-1488-2025; Quantity: 64 units

Product: Monterey AL Implant Inserter (14/16mm)
Variants: 14/16mm
Model / REF:
48019120
Lot Numbers:
231638
UDI:
07613327500998

Recall #: Z-1489-2025; Quantity: 56 units

Product: Monterey AL Implant Inserter (18/20mm)
Variants: 18/20mm
Model / REF:
48019130
Lot Numbers:
231639
UDI:
07613327501049

Recall #: Z-1490-2025; Quantity: 46 units

Product: Monterey AL Implant Inserter (22mm)
Variants: 22mm
Model / REF:
48019140
Lot Numbers:
231640
UDI:
07613327501124

Recall #: Z-1491-2025; Quantity: 44 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96349
Status: Active
Manufacturer: Stryker Spine
Sold By: Stryker Spine; Medical distributors
Manufactured In: United States
Units Affected: 4 products (64 units (60 US, 4 OUS); 56 units (53 US, 3 OUS); 46 units (44 US, 2 OUS); 44 units (41 US, 3 OUS))
Distributed To: California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.