Twelve millimetre distraction pins recalled over unvalidated shelf life labeling
Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 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 12 mm Distraction Pins, REF 301.912S2, supplied sterile in 10 double packs on prescription only, UDI 00850014548070, are being recalled. All lots distributed from August 1, 2020 to July 30, 2025 are covered. The recall involves 160 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: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Hazard
- shelf-life
- labeling-error
- class-ii
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: 00850014548070
Distribution
Distributed nationwide across the United States.
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