Device 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.
Z-0045-2017
Product summary
- Event
- Event 75068
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-0045-2017
Official wording
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
Code information: Lot # 2295101A, 2295101A-R, 2296101A-R
Distribution pattern: US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Derived failure modes
-
Unknown
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