Frontier Devices recalls 160 units of 301.912S2 12 mm distraction pins distributed nationwide. The recall lists shelf-life labeling that has not been validated. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
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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Distraction pins are used in orthopedic procedures to facilitate bone distraction and alignment during treatment.
The hazard relates to shelf-life labeling not being validated, which could impact documentation and traceability of sterility and shelf life rather than an immediate device failure.
This recall is not explicitly described as part of a broader industry pattern.
Hospitals and clinics may need to review inventory and labeling accuracy. No immediate injuries reported, but operational delays may occur.
FDA recall page and manufacturer communications. Serial/date codes on packaging.
Not specified by the recall. Processing timelines typically vary by manufacturer guidance.
Keep recall notice, packaging, model number, lot/date codes, and correspondence with the manufacturer for records.
Model numbers: 301.912S2. Description: 12 mm Distraction Pin, 10 double packs, Rx Only, Sterile. Recall quantity: 160 units. Distribution: Nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX. Sold as Rx Only medical devices by Frontier Devices via Folsom Metal Products, Inc. Recall date: 2025-08-21. Status: ACTIVE.
No injuries or incidents have been reported.
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