RecallRadar

FDA Device recall Z-1489-2025

Monterey AL Implant Inserter

On 2025-04-09 the FDA classified a Class II recall of Monterey AL Implant Inserter by Stryker Spine, citing potential for the gold unlock button to separate from the inserter.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1489-2025
ClassificationClass II
Statusongoing
Initiated2025-02-28
Published2025-04-09
Last updated2026-09-13 11:57 UTC
CompanyStryker Spine
DistributionCA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT

Product

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

Reason

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

Identifiers

code_infoCatalog 48019120; UDI-DI: 07613327500998; Lot Number: 231638;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.