DePuy Spine, Inc. recalls Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (1…
- Recall date
- April 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1225-2019
- FDA classification
- Class II
- Brand / firm
- DePuy Spine, Inc.
- Sold / distributed
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Why it was recalled
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
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