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, PREGNANT
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/Spinal hardware implant accessory
- Model numbers
- 301.916S1
- Sizes
- 16 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
Medical devices used in orthopedic procedures may include distraction pins to aid alignment. This recall involves a sterile, Rx Only pin. Hazard relates to unvalidated shelf life.
Why This Is Dangerous
Shelf life validation ensures that sterility and material integrity remain intact until the product is used. An unvalidated shelf life raises questions about sterility and performance.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate action required by clinicians to avoid potential compromised device effectiveness due to unknown shelf life.
Practical Guidance
How to identify if yours is affected
- Verify model REF 301.916S1
- Check packaging for Sterile, Rx Only labeling
- Confirm lot numbers if available
Where to find product info
Recall letter or FDA enforcement page linked in the provided recall notice
What timeline to expect
Follow manufacturer instructions; replacement or remediation timelines will be communicated in official notices
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA/CFPB if manufacturer unresponsive
- Document all communications
How to prevent similar issues
- Ensure shelf life validation during procurement
- Request updated COAs for sterile devices
- Audit supplier validation processes for shelf life
Documentation advice
Keep recall letters, batch/lot numbers, purchase records, and all communications with provider and manufacturer
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Product Details
Model: 301.916S1. Quantity: 490 units. Sold as: 10 single packs, Rx Only, Sterile. Distributor: Folsom Metal Products. Distribution: US nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX. Recall date: 2025-08-21. Status: ACTIVE.
Reported Incidents
No incidents or injuries are reported in the provided data.
Key Facts
- 16 mm distraction pin
- Shelf life labeling not validated
- Rx Only, Sterile
- States: AL, CA, FL, GA, IL, MD, MI, PA, TX
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Safety Guide
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