United StatesThe XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, part number X073-6555-DL (UDI/DI M697X0736555DL1, Lot 4375-01), two units distributed in Oregon are affected. The lot was recalled because units were mislabeled with an incorrect part number that identified the device as a shorter screw length than it actually is.
What's being recalled
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Recalling firm: XTANT Medical Holdings, Inc, Belgrade, MT, United States.
How to identify it
UDI/DI M697X0736555DL1, Lot Number 4375-01
The hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: OR
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)