Reported Apr 15, 2026 · Ongoing
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
XTANT Medical Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XTANT Medical Holdings, Inc · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Lot codes and dates
UDI/DI M697X0736555DL1Lot Number 4375-01
- Amount recalled
- 2 units
Where it was sold
Why it was recalled
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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