Folsom Metal Products recalled 3,790 distraction pins on August 21, 2025. The recall affects all lots distributed from August 1, 2020, to July 30, 2025. The labeling lacks a validated shelf life, posing a high hazard risk.
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 12 mm Distraction Pin, REF: 301.912S1. It comes in packs of 10 and is distributed nationwide in states including California, Florida, and Texas.
The recall stems from labeling that includes an unvalidated shelf life. This could lead to the use of potentially ineffective or unsafe medical devices.
No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to the nature of medical devices.
Patients and healthcare providers must stop using the recalled distraction pins immediately. Follow the instructions provided by the manufacturer and contact Folsom Metal Products, Inc. for further assistance.
For more information, contact Folsom Metal Products, Inc. at their official website or through the provided FDA recall notification letter.
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