FDA-Device2019-05-08Class II
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
DePuy Spine, Inc.
Hazard
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Sold states
US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Affected count
3166 total
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1225-2019Don't want to check this manually?
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