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.
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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The 301.914S1 Distraction Pin is used in medical settings for various surgical procedures. Consumers purchase it due to its necessity in care protocols that require precise instruments.
The unvalidated shelf life means that patients might use a device that is less effective or entirely ineffective, potentially compromising treatment outcomes.
This recall is not part of a broader industry pattern.
This recall affects patient safety directly as it risks the use of ineffective medical devices.
The model number and shelf life information can typically be found on the packaging or the manufacturer's informational inserts.
Expect a timeline of 4-6 weeks for refund processing.
Keep receipts, correspondence, and any relevant documentation regarding the recall.
Product: 301.914S1 Distraction Pin Quantity: 10,960 units Prescription Type: Rx Only Distribution: US Nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX Recall Date: August 21, 2025
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.
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