PlainRecalls
FDA Devices Moderate Class II Ongoing

Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Reported: September 24, 2025 Initiated: August 21, 2025 #Z-2581-2025

Product Description

Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Reason for Recall

Labeling includes shelf life that has not been validated.

Details

Units Affected
490 units
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Location
Pelham, AL

Frequently Asked Questions

What product was recalled?
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile. Recalled by Folsom Metal Products, Inc.. Units affected: 490 units.
Why was this product recalled?
Labeling includes shelf life that has not been validated.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 24, 2025. Severity: Moderate. Recall number: Z-2581-2025.