Frontier Devices and Folsom Metal Products issued a high-risk recall for 490 units of the 16 mm Distraction Pin, REF 301.916S1, distributed nationwide in the United States. The labeling includes shelf life that has not been validated. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
Labeling includes shelf life that has not been validated.
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
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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.
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.
This recall is not part of a broader industry pattern.
Immediate action required by clinicians to avoid potential compromised device effectiveness due to unknown shelf life.
Recall letter or FDA enforcement page linked in the provided recall notice
Follow manufacturer instructions; replacement or remediation timelines will be communicated in official notices
Keep recall letters, batch/lot numbers, purchase records, and all communications with provider and manufacturer
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.
No incidents or injuries are reported in the provided data.
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