Frontier Devices recall: Labeling Error
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Why was Frontier Devices recalled?
Labeling includes shelf life that has not been validated.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548001
- Product
- Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Recalling firm
- Folsom Metal Products, Inc.
- Quantity
- 3790 unit
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
- Recall date
- September 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)