The Recall Desk

FDA (Devices) recall action 82587

DePuy Spine, Inc. recalled 2 products on 2019-05-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-05-08
Critical
0
Units
6,332

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2019-05-08

    DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration

    DePuy Spine is recalling Concorde Lift spinal fusion implants because a complaint trend was observed for post-operative loss of height and migration.

    Product
    Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-05-08

    DePuy Spine Recalls Concorde Lift Spinal Fusion Implants

    DePuy Spine is recalling Concorde Lift spinal fusion implants due to a complaint trend of post-operative loss of height and migration.

    Product
    Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
    Category
    Distribution
    0 states