FDA Device recall Z-2581-2025
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile by Folsom Metal Products, citing labeling includes shelf life that has not been validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2581-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-21 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Folsom Metal Products |
| Distribution | US |
Product
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Reason
Labeling includes shelf life that has not been validated.
Identifiers
| code_info | All lots distributed from August 1, 2020, to July 30, 2025/UDI:00850014548056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2581-2025%22
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