Folsom Metal Products recalled 160 units of distraction pins due to unvalidated shelf life labeling. The recall affects devices distributed across multiple states, including California and Texas. Patients and healthcare providers should stop using the product immediately.
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 recall involves Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, sold in ten double packs. These devices were distributed nationwide from August 1, 2020, to July 30, 2025.
The recall stems from labeling that includes a shelf life that has not been validated. This lack of validation poses potential health risks to users.
No specific incidents or injuries linked to this recall have been reported at this time. The potential risks arise from the unvalidated shelf life.
Patients and healthcare providers should stop using the distraction pins immediately. Contact Folsom Metal Products, Inc. or your healthcare provider for instructions on the recall.
For more information, reach Folsom Metal Products, Inc. via their official website or through the FDA recall notification letter.
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