Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brands
- Frontier Devices, Folsom Metal Products
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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, Folsom Metal Products
- Product type
- Orthopedic/Implant Hardware
- Model numbers
- 301.912S1
- Sizes
- 12 mm
- Sold at
- Unknown
- 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
Frontier Devices 301.912S1 is a 12 mm distraction pin used in orthopedic or surgical procedures. It comes in sterile packs for medical use.
Why This Is Dangerous
Labeling includes shelf life that has not been validated, which could affect storage and use in medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers may need to adjust inventory and recall procedures; potential regulatory implications for labeling.
Practical Guidance
How to identify if yours is affected
- Check model number 301.912S1 on the device package.
- Confirm packaging indicates 10 single packs per unit.
- Verify sterile, Rx Only designation.
Where to find product info
FDA recall page linked in the article and manufacturer notice.
What timeline to expect
Refund or replacement timelines typically run 4-6 weeks after verification.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Contact FDA recall assistance for guidance.
- Document all communication attempts.
How to prevent similar issues
- Verify shelf life validation data before stocking similar devices.
- Maintain strict inventory control for sterile medical devices.
- Confirm regulatory labeling accuracy before distribution.
Documentation advice
Keep copy of recall notice, FDA page, and all correspondence with the manufacturer.
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Product Details
Brand: Frontier Devices. Model: 301.912S1. Description: 12 mm Distraction Pin. Pack: 10 single packs. Route: Rx Only. Sterile. Distribution: US nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX. Quantity: 3790 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Rx Only sterile device
- Shelf life labeling not validated
- Distribution across AL, CA, FL, GA, IL, MD, MI, PA, TX
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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