FDA recall Z-1489-2025

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-02-28

Report date

2025-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2025