The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1491-2025·Announced 2025-04-09

Stryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation

Stryker Spine is recalling the Monterey AL Implant Inserter (22mm, Catalog 48019140) due to potential separation of the gold unlock button from the device. The recall affects 41 units in the United States and 3 internationally.

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 medical device recall with no reported injuries or illnesses documented in the source text. The identified hazard—potential separation of the unlock button—is theoretical without confirmed patient harm. Per FDA severity criteria, risk-of-harm products where injury has not yet been reported receive a High severity rating.

Plain-English summary

Stryker Spine is recalling the Monterey AL Implant Inserter, 22mm, Catalog Number 48019140. The device is used in spinal surgical procedures.

The recall was initiated due to the potential for the gold unlock button to separate from the inserter. This separation could impact the proper function of the device during surgical use.

The recall affects 44 units total: 41 units distributed in the United States across California, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas, and Utah; and 3 units distributed to Canada. Affected units are identified by Lot Number 231640 and UDI-DI 07613327501124.

FDA Recall Number: Z-1491-2025.

The recalled product

Product
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Manufacturer
Stryker Spine
Category
Medical Device — Surgical Instrument
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 48019140
  • UDI-DI: 07613327501124
  • Lot Number: 231640

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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