DePuy Spine, Inc. recalls Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 2…
- Recall date
- April 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1226-2019
- 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, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
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