Folsom Metal Products recalled 10,960 units of 14 mm Distraction Pins on August 21, 2025. The recall follows concerns that the labeling included an unvalidated shelf life. Healthcare providers and patients must stop using the device 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: 301.914S1, 14 mm Distraction Pins, packaged in 10 single packs. These devices distributed nationwide in states including AL, CA, FL, GA, IL, MD, MI, PA, and TX.
The labeling of these distraction pins includes a shelf life that has not been validated. This poses a risk to patients relying on the device's effectiveness and safety.
No specific incidents or injuries have been reported in connection with this recall. However, the potential for ineffective medical devices raises serious concerns.
Stop using the distraction pins immediately. Follow the recall instructions provided by the manufacturer and contact Folsom Metal Products, Inc. or your healthcare provider for further guidance.
For more information, contact Folsom Metal Products, Inc. at the phone number listed on their website or through the provided recall notification.
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