The Recall Desk

FDA (Devices) recall action 79818

DePuy Orthopaedics, Inc. recalled 2 products on 2018-05-16

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
2018-05-16
Critical
0
Units
3

Why these products were recalled

There may be burrs on the extraction hole threads.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-05-16

    DePuy Recalls ATTUNE Revision Knee Implant Due to Burrs

    DePuy Orthopaedics is recalling a specific femoral revision implant because burrs may be present on the extraction hole threads.

    Product
    ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-05-16

    DePuy Recalls Two Knee Implants Due to Thread Burrs

    DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.

    Product
    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
    Category
    Distribution
    3 states