FDA Device recall Z-0045-2017
ROI-A Anterior Delivery Device
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of ROI-A Anterior Delivery Device by Ldr Spine Usa, citing the ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0045-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-29 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ldr Spine Usa |
| Distribution | AR, FL, GA, KY, NC, OR, PA |
Product
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
Reason
The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury
Identifiers
| code_info | Lot # 2295101A, 2295101A-R, 2296101A-R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2017%22
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