FDAClass IIMay 8, 2019

Concorde Lift recall

Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C)…

Why was Concorde Lift recalled?

A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C)…
Recalling firm
DePuy Spine, Inc.
Quantity
3166 total
Distribution
US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Recall date
May 8, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls