Recall Z-0045-2017 ยท LXH Orthopedic Manual Surgical Instrument
LDR Spine USA, Inc.
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.
| Date | Oct 5, 2016 (initiated Aug 29, 2016) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | 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: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436. |
| Quantity | 24 units |
| Distribution | US Distribution to states of: GA, OR, FL, KY, NC, AR and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM Ldr Spine USA, Feb 2, 2009 |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM Ldr Spine USA, Jun 25, 2009 |
| K113027 | SYNGO AORTIC VALVEGUIDE SOFTWARE Siemens Medical Solutions USA, Inc., Nov 22, 2011 |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System Ldr Spine USA, Mar 31, 2016 |