Home / Recalls / Folsom Metal Products, Inc. / Z-2578-2025

Z-2578-2025 Class II Ongoing

Recalled by Folsom Metal Products, Inc. — Pelham, AL

Recall Details

Product Type
Devices
Report Date
September 24, 2025
Initiation Date
August 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,700 units

Product Description

Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

Reason for Recall

Labeling includes shelf life that has not been validated.

Distribution Pattern

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

Code Information

All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032

Other recalls by Folsom Metal Products, Inc.

  • Z-2579-2025 Class II — Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx On (August 21, 2025)
  • Z-2580-2025 Class II — Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx On (August 21, 2025)
  • Z-2577-2025 Class II — Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx O (August 21, 2025)
  • Z-2576-2025 Class II — Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx On (August 21, 2025)
  • Z-2581-2025 Class II — Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx On (August 21, 2025)
  • Z-0650-2025 Class II — DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that c (October 30, 2023)
  • Z-0651-2025 Class II — Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets (October 30, 2023)