Xpress System Pedicle Screw Assembly — Class II medical device recall Z-1512-2015
Terminated recall by X Spine Systems Inc, reported 2015-04-29, distributed in KS, NV, TX. One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead
| Recall number | Z-1512-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X Spine Systems Inc, Miamisburg, OH, United States |
| Recall initiated | 2015-03-11 |
| Classified | 2015-04-22 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-10-21 |
| Distributed | KS, NV, TX |
| Quantity | 14 units |
| Reason classes | labeling |
| Lot numbers | 4084-01, X073-5555 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1512-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.