FDA recall Z-2576-2025

Folsom Metal Products, Inc. · Class II · device

Product

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Reason for recall

Labeling includes shelf life that has not been validated.

Distribution

US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.

Key facts

Status
Ongoing
Initiation date
2025-08-21
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pelham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2025