Recall Z-1489-2025— Stryker Spine

Name: FDA recall Z-1489-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-28

Class II · Ongoing

Class II FDA medical device recall by Stryker Spine, initiated 2025-02-28. It names one FDA 510(k) clearance: K201585. Product: Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.. Reason: Potential for the gold unlock button to separate from the inserter..

Recalling firm: Stryker Spine
Classification: Class II
Status: Ongoing
Initiated: 2025-02-28
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K201585 — Monterey AL Interbody SystemStryker Corporation·cleared 2020-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.