Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Summary
The FDA issued a Class II for Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx On by Folsom Metal Products, Inc.. Reason: Labeling includes shelf life that has not been validated..
Details
Source
Device Recall
External ID
Z-2581-2025
Action Date
2025-09-24
Status
Ongoing
Category
device
Product Description
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Lot/Code Info: All lots distributed from August 1, 2020, to July 30, 2025/UDI:00850014548056
Quantity Affected: 490 units
Reason for Recall
Labeling includes shelf life that has not been validated.
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-21
Company
Pelham, AL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Folsom Metal Products, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Folsom Metal Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Folsom Metal Products, Inc. have FDA actions?
Folsom Metal Products, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2581-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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