Recall Z-2581-2025— Folsom Metal Products, Inc.

Name: FDA recall Z-2581-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-21

Class II · Ongoing

Class II FDA medical device recall by Folsom Metal Products, Inc., initiated 2025-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile. Reason: Labeling includes shelf life that has not been validated..

Recalling firm: Folsom Metal Products, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-21
Firm location: Pelham, AL, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.