Frontier Devices recalled the 301.914S2 14 mm Distraction Pin distributed nationwide in the US. The recall was issued for labeling that includes shelf life not validated. Patients and healthcare providers should stop using the device immediately and follow manufacturer 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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Frontier Devices produces specialized medical components such as distraction pins used in orthopedic procedures. These devices are Rx Only and sterile.
An unvalidated shelf-life label can compromise product tracking and sterility assurances, potentially affecting device performance.
This recall is not described as part of a broader industry pattern in the notice.
The recall prioritizes patient safety by halting use until shelf-life labeling is validated, with potential implications for sterility and inventory control.
Visit the FDA enforcement page for recall Z-2580-2025 or contact the manufacturer
No timelines provided in notice; follow manufacturer instructions and FDA updates
Keep copy of recall notice, packaging, and all correspondence; document lot numbers and serial numbers
Brand: Frontier Devices. Model: 301.914S2. Quantity: All lots distributed from Aug 1, 2020, to July 30, 2025. Size: 14 mm. Packaging: 10 double packs. Status: Active recall. Sold as Rx Only and sterile. UDI: 00850014548032. Distribution: United States nationwide (AL, CA, FL, GA, IL, MD, MI, PA, TX).
No specific injuries or incidents are described in the recall notice. The document indicates a labeling concern rather than a device malfunction causing injury.
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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.
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Frontier Devices recalled 10,960 units of the 301.914S1 Distraction Pin due to unvalidated shelf life labels. The recall affects medical professionals and patients who use this device risk relying on potentially inaccurate lifespan data. Users should stop using the distraction pin immediately and contact their healthcare provider or Folsom Metal Products for further instructions.