The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1490-2025·Announced 2025-04-09

Stryker Spine Monterey AL Implant Inserter Recall Due to Potential Gold Button Separation

Stryker Spine is recalling the Monterey AL Implant Inserter because the gold unlock button may separate from the device, which could affect functionality during surgical procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a potential component defect in a surgical device that could affect device functionality. The hazard constitutes a risk-of-harm product, but no illnesses or injuries have been reported. Per the severity rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3 (High).

Plain-English summary

Stryker Spine is recalling the Monterey AL Implant Inserter (Catalog 48019130) due to a potential defect in which the gold unlock button may separate from the inserter. This component separation could compromise the device's intended functionality.

46 units have been affected (44 in the United States and 2 internationally). The devices were distributed to facilities in California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, and Utah, as well as Canada. The affected product has Lot Number 231639 and UDI-DI 07613327501049.

Healthcare providers should stop using the affected devices immediately. Stryker Spine recommends contacting the company for return instructions and information about replacement devices. No illnesses or injuries have been reported related to this defect.

The recalled product

Product
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Manufacturer
Stryker Spine
Category
Medical Device — Spinal Implant
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalog 48019130
  • UDI-DI: 07613327501049
  • Lot Number: 231639

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 4 recalled by Stryker Spine under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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