Frontier Devices 12 mm Distraction Pins Recalled for Unvalidated Shelf Life
Folsom Metal Products is recalling 3790 units of Frontier Devices 12 mm Distraction Pins due to unvalidated shelf life labeling. Users should contact their healthcare provider for guidance.
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: This is a FDA Class II recall for a labeling issue with no reported illnesses, injuries, or adverse events. Unvalidated shelf life is a documentation problem, not a confirmed product defect, fitting the pattern of minor labeling errors.
Plain-English summary
Folsom Metal Products, Inc. is recalling certain Frontier Devices 12 mm Distraction Pins (REF: 301.912S1) distributed nationwide. The product is a sterile, prescription-only medical device.
The recall was issued because the labeling includes a shelf life that has not been validated. This means the manufacturer did not conduct testing to confirm that the stated shelf life on the label is accurate.
The recall affects 3790 units distributed from August 1, 2020, to July 30, 2025, across Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas. Healthcare providers and facilities that received these devices should contact their healthcare provider for guidance on device replacement or further use.
The recalled product
- Product
- Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Category
- Medical Device
- Hazard
- labeling-error
- shelf-life-validation
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: 00850014548001
Distribution
Distributed nationwide across the United States.
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