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Unrated Medical device recall · FDA · Published February 28, 2025

Stryker Spine Monterey AL Implant Inserter Recall: Gold Button May Separate

Stryker Spine recalls Monterey AL Implant Inserter (14/16mm, Catalog 48019120) due to potential gold unlock button separation. Affected units have specific identifiers; contact for remedy.

🇺🇸 FDA recall #Z-1489-2025Medical deviceStryker Spine ›
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Recalling firmStryker Spine59 State Rt 17 S · Allendale, NJ 07401-1614
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker Spine is recalling Monterey AL Implant Inserter devices (14/16mm, Catalog 48019120) because the gold unlock button might separate. This could lead to improper use during spinal surgery. Patients and medical staff using these devices should check their identifiers and contact Stryker Spine for guidance. Read more at govinfonow.com/recall/52726-stryker-spine-monterey-al-implant-inserter-recall-gold-button-may.

Source Summary by GovInfoNow · govinfonow.com/recall/52726-stryker-spine-monterey-al-implant-inserter-recall-gold-button-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1489-2025

Cite this page

“Stryker Spine Monterey AL Implant Inserter Recall: Gold Button May Separate.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52726-stryker-spine-monterey-al-implant-inserter-recall-gold-button-may. Based on FDA recall #Z-1489-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2025%22&limit=1).

Why it’s dangerous

The gold unlock button on the Monterey AL Implant Inserter could separate during use, potentially causing improper insertion of spinal implants. This might lead to surgical complications if the button fails to function correctly.

Who’s affected

Medical professionals and patients using the Monterey AL Implant Inserter for spinal procedures are likely affected. Those with the specific catalog number or lot number are at risk.

How to tell if you have this one

Check for the catalog number 48019120 and lot number 231638 on the device. The product is sold under the Monterey AL Implant Inserter (14/16mm) model.

  • Brand
    Stryker Spine
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Recall numberProduct, codes & lotsQuantity
Z-1488-2025Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.; Catalog 48019100; UDI-DI: 07613327456462; Lot Number: 231634;64 units (60 US, 4 OUS)
Z-1489-2025Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.; Catalog 48019120; UDI-DI: 07613327500998; Lot Number: 231638;56 units (53 US, 3 OUS)
Z-1490-2025Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.; Catalog 48019130; UDI-DI: 07613327501049; Lot Number: 231639;46 units (44 US, 2 OUS)
Z-1491-2025Monterey AL Implant Inserter; 22mm; Catalog 48019140.; Catalog 48019140; UDI-DI: 07613327501124; Lot Number: 231640;44 units (41 US, 3 OUS)
Based on the official FDA remedy

What to do — step by step

  1. Check Device Identifiers

    Look for catalog number 48019120 and lot number 231638 on the Monterey AL Implant Inserter.

Where it went and when

Where it was distributed

Distributed in 13 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, Utah.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Feb 28, 202512. FDA classified it Class II: Mar 31, 202523. Published in FDA’s Enforcement Report: Apr 9, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-1489-2025 (February 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1489-2025 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA