The Recall Desk

FDA (Devices) recall action 79072

DePuy Orthopaedics, Inc. recalled 2 products on 2018-03-14

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
2018-03-14
Critical
0
Units
260

Why these products were recalled

Potential for Intra-operative breakage of driver tips

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

  • HighFDA (Devices)··2018-03-14

    DePuy Concorde Lift Torque Limiting Handle Recalled for Breakage Risk

    DePuy Orthopaedics is recalling 130 Concorde Lift Torque Limiting Handles due to a potential for intra-operative breakage of driver tips.

    Product
    Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-03-14

    DePuy Concorde Lift Driver Shaft Recalled for Potential Breakage

    DePuy Orthopaedics is recalling 130 units of the Concorde Lift Driver Shaft AO due to a potential for intra-operative breakage of driver tips.

    Product
    Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
    Category
    Distribution
    0 states