Z-2578-2025 Class II Ongoing
FDA device recall Z-2578-2025 was initiated by Folsom Metal Products, Inc. on Aug 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: 2,700 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 24, 2025
- Initiation Date
- Aug 21, 2025
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2578-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026