CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report
Xtant Medical Xpress Pedicle Screw System Dual Lead recalled
Xtant Medical Holdings is recalling Xtant Medical Xpress Pedicle Screw System Dual Lead, distributed in Oregon. The recall was initiated on 18 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1773-2026
- FDA event ID
- 98541
- Recalling firm
- Xtant Medical Holdings, Belgrade, MT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Feb 2026
- FDA classified
- 3 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Spinal Implants
Timeline
| 18 Feb 2026 | Recall initiated by company | |
| 3 Apr 2026 | Classified by FDA | +44 days |
| 15 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Product as listed by the FDA
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Where it was distributed
US: OR
Questions about this recall
Why was it recalled?
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Which lots are affected?
UDI/DI M697X0736555DL1, Lot Number 4375-01
Where was it sold?
US: OR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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