Recall Z-1226-2019— DePuy Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Spine, Inc., initiated 2019-04-08, terminated 2023-01-12. It names 2 FDA 510(k) clearances: K160464, K152156. Product: Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L). Reason: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants..
- Recalling firm
- DePuy Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-08
- Terminated
- 2023-01-12
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K160464 — Opticage(R) Expandable Interbody Fusion Device
- K152156 — Opticage Expandable Interbody Fusion Device
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Reason for recall
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Data sourced from openFDA. This site is unofficial and independent of the FDA.