Reported Apr 9, 2025 · Ongoing

Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

Stryker Spine

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Spine · 59 State Rt 17 S · Allendale, NJ · 07401-1614

Is this the product you have?

    • Monterey AL Implant Inserter
    • 10/12mm
    • Catalog 48019100
Lot codes and dates
  • Catalog 48019100
  • UDI-DI07613327456462
  • Lot Number231634
Amount recalled
64 units (60 US, 4 OUS)

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.