Z-0045-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- August 29, 2016
- Termination Date
- January 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
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
Distribution Pattern
US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Code Information
Lot # 2295101A, 2295101A-R, 2296101A-R