Stryker Spine: Device Recall

Recall #Z-1489-2025 · 02/28/2025

Class II: Risk

Recall Details

Recall Number: Z-1489-2025
Classification: Class II
Product Type: Device
Recalling Firm: Stryker Spine
Status: Ongoing
Date Initiated: 02/28/2025
Location: Allendale, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56 units (53 US, 3 OUS)

Reason for Recall

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

Product Description

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

Distribution Pattern

Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.

Other Recalls by Stryker Spine

Class II: Risk 02/28/2025

Potential for the gold unlock button to separate from the inserter.
Class II: Risk 02/28/2025

Potential for the gold unlock button to separate from the inserter.
Class II: Risk 02/28/2025

Potential for the gold unlock button to separate from the inserter.
Class II: Risk 08/23/2024

Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

View all recalls by Stryker Spine →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.