Device 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.
Z-1512-2015
Product summary
- Event
- Event 70774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-1512-2015
Official wording
Reason: One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
Code information: Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
Distribution pattern: US Distribution to states of: KS, NV & TX.
Derived failure modes
-
Unknown
One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.