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.
Recall
- Recall Number
- Z-0045-2017
- Event Number
- 75068
- Firm
- LDR Spine USA, Inc.
- FEI Number
- 3004903783
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 29, 2016
- Posted
- October 5, 2016
- Terminated
- January 13, 2017
- Address
- 13785 Research Blvd, Ste 200, Austin, TX, 78750-1895
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.
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
The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur. If you have any question, contact the Quality Engineering Manager by email: [email protected], phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.
US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
24 units