Devices

Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm

Model / Serial
Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution to states of: KS, NV & TX.
Product Description
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
1 Event
- Recall of Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm

Manufacturer

X Spine Systems Inc

Manufacturer Address
X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
Manufacturer Parent Company (2017)
X-Spine Systems, Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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