Frontier Devices 16mm Distraction Pin Recall Due to Unvalidated Shelf Life
Folsom Metal Products is recalling 490 units of Frontier Devices 16mm Distraction Pins nationwide due to unvalidated shelf life labeling. The label claim has not been substantiated.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves unvalidated shelf life labeling on a sterile surgical device with no reported illnesses or injuries. Per the rubric, theoretical risk-of-harm to product safety (sterility assurance) without reported injury scores 3 (High).
Plain-English summary
Folsom Metal Products, Inc. is recalling 490 units of Frontier Devices, REF: 301.916S1, 16mm Distraction Pins. The affected products were distributed from August 1, 2020, through July 30, 2025, in the states of Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas.
The distraction pin is a sterile surgical device (Rx Only). The recall is due to labeling that includes a shelf life claim that has not been validated. An unvalidated shelf life on a sterile product raises concerns about whether the product will maintain its sterility and safety characteristics throughout the claimed shelf life period.
This is a Class II recall issued by the FDA. The recall number is Z-2581-2025. Affected healthcare facilities should contact Folsom Metal Products regarding this recall.
The recalled product
- Product
- Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Hazard
- unvalidated-shelf-life
- sterility-assurance
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:00850014548056
Distribution
Distributed nationwide across the United States.
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