FDA recall Z-1225-2019

DePuy Spine, Inc. · Class II · device

Product

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.

Distribution

US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.

Key facts

Status: Terminated
Initiation date: 2019-04-08
Report date: 2019-05-08
Termination date: 2023-01-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1225-2019