Folsom Metal Products recalled 10 double packs of 14 mm Distraction Pins on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Healthcare providers and patients must stop using these devices 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 14 mm Distraction Pin, REF: 301.914S2. The recall includes all lots distributed from August 1, 2020, to July 30, 2025. These devices were distributed nationwide in states including Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, and Texas.
The recall stems from labeling that includes a shelf life that has not been validated. This presents a risk that the device may not perform as intended after an unspecified period.
There have been no reported incidents or injuries associated with the recalled distraction pins. The potential for misuse remains a concern due to the lack of validated shelf life.
Patients and healthcare providers should immediately stop using the recalled distraction pins. Follow the recall instructions provided by the manufacturer and contact Folsom Metal Products for further guidance.
For more information, contact Folsom Metal Products, Inc. You can visit the official FDA recall page for additional details.
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