Xpress System Pedicle Screw Assembly Recalled for Incorrect Laser Marking
X Spine Systems Inc is recalling 14 units of Xpress System Pedicle Screw Assemblies because the laser marking on the yoke incorrectly states 7.5 x 55mm instead of 5.5 x 55mm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (incorrect laser marking) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
X Spine Systems Inc is recalling 14 units of the Xpress System Pedicle Screw Assembly, 5.5 x 55mm. This internal fixation device is used for spinal surgery and consists of rods, pedicle screw assemblies, and cross bar connector assemblies.
The recall is due to a labeling error where the laser marking etched on the Yoke of the Pedicle Screw indicates a size of 7.5 x 55mm, whereas the product label correctly describes the size as 5.5 x 55mm. The affected lot number is 4084-01, with model number X073-5555 and UDI *+M697X07355551/$408401U*.
The affected units were distributed in the United States to the states of Kansas, Nevada, and Texas. Healthcare providers and facilities should check their inventory for this specific lot and stop using the affected devices.
The recalled product
- Product
- Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
- Manufacturer
- X Spine Systems Inc
- Hazard
- Affected units
- 14
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 (3)
- Lot #: 4084-01
- M/N X073-5555
- UDI: *+M697X07355551/$408401U*
Distribution
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