Frontier Devices recalled 2,700 units of REF 301.914S1 14 mm Distraction Pin sold nationwide by multiple retailers. The labeling includes shelf life that has not been validated. Healthcare providers and patients should stop using this device immediately and follow the manufacturer’s recall 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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The device is a 14 mm distraction pin used in orthopedic procedures. It is labeled Rx Only and shipped sterile. The recall concerns shelf-life labeling rather than the device’s functional integrity.
If shelf life labeling is not validated, there is a potential risk that the device may be used outside validated expiry or storage conditions, compromising sterility or performance.
This recall is not described as part of a broader industry pattern.
Hospitals and clinicians must identify affected devices and follow recall instructions to avoid using non-validated labeled sterile devices.
Label on the device packaging shows REF 301.914S1. Recall details available on the FDA enforcement page linked in the notice.
Replacement or disposal instructions will be provided by the manufacturer; processing timelines vary, often several weeks.
Keep the recall letter, take photos of the device label, record model and lot information, and save all communications with the manufacturer.
Model: REF: 301.914S1. Distribution: US nationwide in AL, CA, FL, GA, IL, MD, MI, PA, TX. Recall date: 2025-08-21. Report date: 2025-09-24. Quantity: 2,700 units. Price: Unknown. Manufacturer/Distributor: Frontier Devices; Distributor/Manufacturer contact: Folsom Metal Products, Inc.
No injuries or incidents have been reported.
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