Recall Z-1225-2019— 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 one FDA 510(k) clearance: K171425. Product: Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C). 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
1 on FDA's recordK-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, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
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.