Xtant pedicle screws mislabeled with an incorrect shorter screw length
Xtant Medical is recalling Xpress Pedicle Screw System dual lead screws from one lot that were mislabeled with a part number identifying them as shorter than they physically are.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall where a mislabeled implant dimension could lead to the wrong size being implanted, a risk of harm with no injuries reported in the source.
Plain-English summary
Xtant Medical is recalling the Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, part number X073-6555-DL, UDI/DI M697X0736555DL1, lot number 4375-01. The action covers two units.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. A pedicle screw that is longer than the label states can be selected and implanted on the basis of the wrong dimension. The FDA classified the action as Class II.
Distribution was within the United States, in Oregon. The screws are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the part number, UDI and lot number in the recall notice, quarantine it, and follow the instructions issued by Xtant Medical.
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 — Spinal implant
- Affected units
- 2
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:
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