[pending] XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Pending LLM rewrite. Source: FDA_DEVICE Z-1773-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
The recalled product
- Product
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Manufacturer
- XTANT Medical Holdings, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI M697X0736555DL1
- Lot Number 4375-01
Distribution
Distributed in 1 state:
- OR
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