XTANT Medical Holdings recalls 2 units of the Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm due to mislabeled lot that misidentifies screw length. The recall affects units distributed in the US, specifically Oregon. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions for recall actions.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact XTANT Medical Holdings, Inc or your healthcare provider for instructions. Notification method: Letter
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Pedicle screws are used in spinal fusion surgeries to anchor implants to vertebrae. The Xpress Dual Lead 6.5 x 50 mm is a specific length used in certain procedures.
Mislabeled length could lead to selection of the wrong screw during surgery, potentially impacting fixation. Exact risk is determined by surgical context.
This recall is not part of a broader industry pattern.
Immediate usage halt to protect patients; providers must verify labeling before any procedure and coordinate with XTANT for next steps.
UDI label on device packaging; lot sticker on container; hospital records
Coordinate with manufacturer for replacement; recall processing details to follow
Keep recall letter, serials, lot numbers, and replacement instructions; document patient impact and outcomes.
Brand: XTANT Medical Holdings. Product: Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm. Part Number: X073-6555-DL. UDI/DI: M697X0736555DL1. Lot Number: 4375-01. Units recalled: 2. Distribution: United States, Oregon (OR). Recall date: 2026-02-18. Status: Active.
0 injuries or incidents reported in the provided data.
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