Distraction Pin Recall Due to Unvalidated Shelf Life Labeling
Folsom Metal Products is recalling 14 mm Distraction Pins with unvalidated shelf life labeling. The recall affects approximately 10,960 units distributed nationwide.
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 Class II recall involves unvalidated shelf life labeling on a sterile medical device, creating a potential risk of harm if the device is used beyond its actual safe period. No illnesses or injuries have been reported, limiting the severity to High (3) per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Folsom Metal Products, Inc. is recalling 14 mm Distraction Pins (REF: 301.914S1) distributed as 10 single packs under the Frontier Devices brand. These are sterile, prescription-only medical devices used in orthopedic and spinal applications. The recall involves 10,960 units.
The devices are being recalled because their labeling includes a shelf life expiration that has not been validated. This unvalidated expiration date creates uncertainty regarding the actual safe use period of the sterile device.
The affected devices were distributed nationwide to healthcare facilities in Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas. All lots distributed from August 1, 2020, through July 30, 2025 are included in the recall.
Healthcare facilities and clinicians should contact Folsom Metal Products, Inc. or the FDA for instructions regarding this recall.
The recalled product
- Product
- Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Manufacturer
- Folsom Metal Products, Inc.
- Hazard
- 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: 00850014548032
Distribution
Distributed nationwide across the United States.
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