XTANT Medical recalls specific Xpress Pedicle Screw System units with mislabeled part numbers that may not match the actual screw length. Affected units have a unique lot number and part number.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
XTANT Medical is recalling a specific type of surgical screw system because some units were mislabeled with the wrong part number. This could mean the screws are actually longer than labeled, which might cause complications during surgery.
The mislabeled part number indicates the device is physically longer than the labeled size. This could lead to improper screw placement during spinal surgery, potentially causing complications like nerve damage or instability.
Surgical teams using the XTANT Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm with part number X073-6555-DL are most at risk. Patients undergoing spinal surgery may be affected if the incorrect labeling leads to improper screw placement.
Check for the part number X073-6555-DL and lot number 4375-01 on the device's packaging or UDI/DI label. The device is sold under the brand XTANT Medical.
Look for the part number X073-6555-DL and lot number 4375-01 on the device's packaging or UDI/DI label.
The units were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Check the device label for part number X073-6555-DL and lot number 4375-01. If you have these identifiers, contact XTANT Medical for further instructions.
The recall is for mislabeling that could lead to improper screw placement during surgery, but the hazard is not described as causing immediate serious injury in normal use.
We’ve drafted a message you can send XTANT Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1773-2026 — XTANT Medical XTANT Medical Hello, I own a XTANT Medical that is covered by recall Z-1773-2026 from XTANT Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
