ROI-A Anterior Delivery Device — Class II medical device recall Z-0045-2017
Terminated recall by LDR Spine USA, Inc., reported 2016-10-12, distributed in AR, FL, GA, KY, NC, OR, PA. The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation
| Recall number | Z-0045-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LDR Spine USA, Inc., Austin, TX, United States |
| Recall initiated | 2016-08-29 |
| Classified | 2016-10-05 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-01-13 |
| Distributed | AR, FL, GA, KY, NC, OR, PA |
| Quantity | 24 units |
| Lot numbers | 2295101A, 2295101A-R, 2296101A-R |
| Model numbers | SI-ROIA-0023 |
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 for recall
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
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-0045-2017. 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.