Recall Z-0848-2018 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
DePuy Orthopaedics, Inc.
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
| Date | Jul 26, 2017 |
| Status | Terminated |
| Reason | Potential for Intra-operative breakage of driver tips |
| Root cause | Under Investigation by firm |
| Action | On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be |
| Quantity | 130 units total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171425 | CONCORDE LIFT Medos International SARL, Jul 20, 2017 |