Fourteen millimetre distraction pins recalled over unvalidated shelf life labeling
Frontier Devices 14 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 10,960 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is an unvalidated shelf life on the label rather than a defect described in the product.
Plain-English summary
Frontier Devices 14 mm Distraction Pins, REF 301.914S1, supplied sterile in 10 single packs on prescription only, UDI 00850014548032, are being recalled. All lots distributed from August 1, 2020 to July 30, 2025 are covered. The recall involves 10,960 units distributed in Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania and Texas.
The recall was issued because the labeling includes a shelf life that has not been validated. The FDA classified the action as Class II. The notice does not describe a defect in the pins.
Hospitals and surgical centres holding this product should follow the manufacturer's instructions for affected stock.
The recalled product
- Product
- Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Affected units
- 10,960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All lots distributed from August 1
- 2020
- to July 30
- 2025/UDI: 00850014548032
Distribution
Part of a larger recall action
This product is one of 6 recalled by Folsom Metal Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Folsom Metal Products, Inc.
See all →- ModerateDistraction pins in single packs recalled over shelf life that was not validated
FDA (Devices) · 2025-09-24
- ModerateSixteen millimetre distraction pins recalled over unvalidated shelf life labeling
FDA (Devices) · 2025-09-24
- ModerateDistraction pins in five packs recalled over unvalidated shelf life
FDA (Devices) · 2025-09-24
- ModerateDistraction pins in double packs recalled over unvalidated shelf life labeling
FDA (Devices) · 2025-09-24
- ModerateTwelve millimetre distraction pins recalled over unvalidated shelf life labeling
FDA (Devices) · 2025-09-24
Same hazard · shelf life
See all →- HighCook Medical Spectrum central venous catheter trays carry overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical multipurpose drainage catheters carry overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical pneumothorax tray labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
- HighCook Medical tracheostomy introducer sets labeled with overstated expiration dates
FDA (Devices) · 2026-04-15