Device product
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Z-2579-2025
Product summary
- Event
- Event 97480
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,960 units
- Official record key
device-enforcement:Z-2579-2025
Official wording
Reason: Labeling includes shelf life that has not been validated.
Code information: All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032
Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Derived failure modes
-
Unknown
Labeling includes shelf life that has not been validated.