Frontier Devices 14 mm Distraction Pin Recall: Unvalidated Shelf Life Labeling
Folsom Metal Products recalled 2,700 units of Frontier Devices distraction pins due to labeling that includes shelf life that has not been validated. The recall affects devices distributed nationwide from August 2020 to July 2025.
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: FDA Class II recall for unvalidated shelf life labeling on a sterile medical device. No illnesses or injuries have been reported, making this primarily a labeling and documentation defect.
Plain-English summary
Folsom Metal Products has recalled 2,700 units of the Frontier Devices 14 mm Distraction Pin (REF: 301.914S1) distributed nationwide. This is a sterile, prescription-only medical device.
The recall was issued because the labeling includes shelf life information that has not been validated.
All affected lots were distributed from August 1, 2020 through July 30, 2025 across Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas. Affected units can be identified using the UDI: 00850014548032.
Individuals with affected devices or questions about this recall should contact Folsom Metal Products or speak with their healthcare provider.
The recalled product
- Product
- Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Category
- Medical Device — Surgical Device
- Hazard
- unvalidated-shelf-life
- labeling-error
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
Distributed nationwide across the United States.
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