Data Foundry

Medical device recalls 2025

Monterey AL Implant Inserter — Class II medical device recall Z-1491-2025

Ongoing recall by Stryker Spine, reported 2025-04-09, distributed in CA, CO, FL, GA, IL, MA, NE, NH…. Potential for the gold unlock button to separate from the inserter.

Recall numberZ-1491-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStryker Spine, Allendale, NJ, United States
Recall initiated2025-02-28
Classified2025-03-31
Reported by FDA2025-04-09
DistributedCA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT
Countries outside the USCA
UPC / GTIN / UDI-DI07613327501124
Lot numbers231640
Model numbers48019140

Product

Monterey AL Implant Inserter; 22mm; Catalog 48019140.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1491-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.