FDA Device recall Z-1512-2015
Xpress System Pedicle Screw Assembly, 5.5 x 55mm
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of Xpress System Pedicle Screw Assembly, 5.5 x 55mm by X Spine Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1512-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-11 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | X Spine Systems |
| Distribution | KS, NV, TX |
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.
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.
Identifiers
| code_info | Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U* |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2015%22
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