Folsom Metal Products recalled 490 units of its 16 mm distraction pin on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Patients and healthcare providers 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 recalled product is the 16 mm distraction pin, REF: 301.916S1, sold in 10 single packs. It has been distributed nationwide in states including California, Florida, and Texas.
The labeling of these distraction pins includes a shelf life that has not been validated. This could lead to the use of ineffective or unsafe medical devices.
There are no reported incidents or injuries related to this recall. The recall is precautionary due to labeling issues.
Stop using the distraction pins immediately. Contact Folsom Metal Products, Inc. or your healthcare provider for further instructions.
For more information, visit the FDA website or contact Folsom Metal Products, Inc. directly at their customer service number.
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