Medtronic CD HORIZON Spinal System is intended to help provide… — Class II medical device recall Z-2603-2018
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2018-08-15. This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attac
| Recall number | Z-2603-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2018-07-09 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2021-05-07 |
| Quantity | 47 units |
| Lot numbers | 0648247W |
| Model numbers | 55840005045 |
Product
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
Reason for recall
This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
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-2603-2018. 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.