Frontier Devices 12 mm Distraction Pins Recalled for Unvalidated Shelf Life Labeling
Folsom Metal Products is recalling Frontier Devices 12 mm Distraction Pins due to labeling that includes unvalidated shelf life. The recall affects 160 units distributed nationwide from August 2020 through 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 a labeling error involving unvalidated shelf life on a sterile device, with no reported illnesses or injuries. The hazard is theoretical, not confirmed.
Plain-English summary
Folsom Metal Products, Inc. is recalling Frontier Devices 12 mm Distraction Pins (REF: 301.912S2), a sterile surgical device distributed in packages of 10 double packs. The recall includes 160 units distributed nationwide to healthcare facilities in multiple states.
The distraction pins are being recalled because the labeling includes a shelf life that has not been validated. This means the expiration date or shelf life displayed on the package has not been confirmed through proper stability testing.
The recall affects healthcare providers and facilities in Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas who received these devices. All lots distributed between August 1, 2020 and July 30, 2025 are included in this recall.
Healthcare providers who have received these pins should stop using them and contact Folsom Metal Products for instructions on return or replacement. The device is prescription-use only.
The recalled product
- Product
- Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Category
- Medical Device — Surgical Device
- Hazard
- mis-labeling
- unvalidated-shelf-life
- sterility-risk
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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