Z-1512-2015 Class II Terminated
FDA device recall Z-1512-2015 was initiated by X Spine Systems Inc on March 11, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated October 21, 2015). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- March 11, 2015
- Termination Date
- October 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
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.
Reason for Recall
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.
Distribution Pattern
US Distribution to states of: KS, NV & TX.
Code Information
Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*