PlainRecalls
FDA Devices Moderate Class II Ongoing

Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

Reported: April 9, 2025 Initiated: February 28, 2025 #Z-1489-2025

Product Description

Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

Reason for Recall

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

Details

Recalling Firm
Stryker Spine
Units Affected
56 units (53 US, 3 OUS)
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Location
Allendale, NJ

Frequently Asked Questions

What product was recalled?
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.. Recalled by Stryker Spine. Units affected: 56 units (53 US, 3 OUS).
Why was this product recalled?
Potential for the gold unlock button to separate from the inserter.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1489-2025.