Folsom Metal Products recalled 2,700 units of distraction pins on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Patients and healthcare providers must 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 includes Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin sold in 5 single packs. The affected units were distributed nationwide in the U.S. from August 1, 2020, to July 30, 2025.
The recall stems from unvalidated shelf life labeling. Use of such devices could lead to ineffective treatment.
There are no reported incidents or injuries associated with this recall at this time. The recall is classified as Class II, indicating a potential for temporary health issues.
Stop using the device immediately. Contact Folsom Metal Products or your healthcare provider for further instructions.
For more information, visit the FDA website or contact Folsom Metal Products directly. Recall notification was sent via letter.
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