FDA Enforcement
Class II
Ongoing
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Recall: Z-2578-2025
·
Reported September 24, 2025
Enforcement
- Recall Number
- Z-2578-2025
- Event ID
- 97480
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Folsom Metal Products, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 24, 2025
- Initiation Date
- August 21, 2025
- Classification Date
- September 17, 2025
- Address
- 1449 Court Pl, N/A, Pelham, AL, 35124-1858, United States
Description
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Reason
Labeling includes shelf life that has not been validated.
Code Info
All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Quantity
2,700 units