Distraction pins in double packs recalled over unvalidated shelf life labeling
Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 301.914S2, supplied sterile in 10 double packs on prescription only, UDI 00850014548032, are being recalled. All lots distributed from August 1, 2020 to July 30, 2025 are covered. Distribution was 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: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
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.
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