Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brand
- Frontier Devices
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Frontier Devices
- Product type
- 12 mm Distraction Pin
- Model numbers
- 301.912S2
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 21, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling includes shelf life that has not been validated.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Folsom Metal Products, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Distraction pins are used in orthopedic procedures to facilitate bone distraction and alignment during treatment.
Why This Is Dangerous
The hazard relates to shelf-life labeling not being validated, which could impact documentation and traceability of sterility and shelf life rather than an immediate device failure.
Industry Context
This recall is not explicitly described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to review inventory and labeling accuracy. No immediate injuries reported, but operational delays may occur.
Practical Guidance
How to identify if yours is affected
- Check model number 301.912S2 on the device label.
- Verify that shelf-life labeling appears validated on the packaging.
- Refer to recall notice for any lot numbers or serials.
Where to find product info
FDA recall page and manufacturer communications. Serial/date codes on packaging.
What timeline to expect
Not specified by the recall. Processing timelines typically vary by manufacturer guidance.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Consider filing a report with the FDA if the manufacturer is unresponsive.
How to prevent similar issues
- Verify shelf-life validation before procurement.
- Ask suppliers for shelf-life validation documentation.
- Only use devices within validated shelf life and maintain proper inventory controls.
Documentation advice
Keep recall notice, packaging, model number, lot/date codes, and correspondence with the manufacturer for records.
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Product Details
Model numbers: 301.912S2. Description: 12 mm Distraction Pin, 10 double packs, Rx Only, Sterile. Recall quantity: 160 units. Distribution: Nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX. Sold as Rx Only medical devices by Frontier Devices via Folsom Metal Products, Inc. Recall date: 2025-08-21. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Shelf-life labeling not validated
- Nationwide distribution in AL, CA, FL, GA, IL, MD, MI, PA, TX
- Rx Only, Sterile
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Safety Guide
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