FDA Medical devices recall ·
Frontier Devices recall
- Recall number
- Z-2577-2025
- Date
- (initiated August 21, 2025)
- Company / brand
- Folsom Metal Products, Inc.
1449 Court Pl, Pelham, AL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Why was it recalled?
Labeling includes shelf life that has not been validated.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548070
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
States: Alabama California Florida Georgia Illinois Maryland Michigan Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2577-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.