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.
What this means for you
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
- Hazard
- component-separation
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:
- CA
- CO
- FL
- GA
- IL
- MA
- NE
- NH
- NY
- OK
- PA
- TX
- UT
Related recalls
Same category
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27