Z-2577-2025 Class II Ongoing
FDA device recall Z-2577-2025 was initiated by Folsom Metal Products, Inc. on August 21, 2025 and is designated Class II. Reason for recall: Labeling includes shelf life that has not been validated. The recall status is ongoing. Affected quantity: 160 units.
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
- 160 units
Product Description
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double 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: 00850014548070