Frontier Devices recalled 3,790 units of the 12 mm Distraction Pin, REF 301.912S1, distributed nationwide in the United States. The recall cites labeling that includes shelf life which has not been validated. The high-risk device category reflects potential documentation and shelf-life concerns. Healthcare providers and patients should follow recall instructions and contact the manufacturer for a回
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 301.912S1 is a 12 mm distraction pin used in orthopedic or surgical procedures. It comes in sterile packs for medical use.
Labeling includes shelf life that has not been validated, which could affect storage and use in medical procedures.
This recall is not part of a broader industry pattern.
Healthcare providers may need to adjust inventory and recall procedures; potential regulatory implications for labeling.
FDA recall page linked in the article and manufacturer notice.
Refund or replacement timelines typically run 4-6 weeks after verification.
Keep copy of recall notice, FDA page, and all correspondence with the manufacturer.
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.
No injuries or incidents have been reported.
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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.
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.
Frontier Devices recalls 160 units of 301.912S2 12 mm distraction pins distributed nationwide. The recall lists shelf-life labeling that has not been validated. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
Frontier Devices recalled 2,700 units of REF 301.914S1 14 mm Distraction Pin sold nationwide by multiple retailers. The labeling includes shelf life that has not been validated. Healthcare providers and patients should stop using this device immediately and follow the manufacturer’s recall instructions.
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.