The Recall Desk

FDA (Devices) recall action 87433

DePuy Orthopaedics, Inc. recalled 3 products on 2021-04-07

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-04-07
Critical
0
Units
—

Why these products were recalled

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2021-04-07

    DePuy ATTUNE Rotating Platform Total Knee System Recalled for Damaged Packaging

    DePuy Orthopaedics is recalling 355 units of the ATTUNE Rotating Platform Total Knee System due to potential damaged packaging. The affected tibial bases are used in cemented total knee arthroplasty.

    Product
    The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-04-07

    DePuy ATTUNE Knee Implant Recall for Damaged Packaging

    DePuy Orthopaedics is recalling ATTUNE and MBT tibial base components used in knee replacements due to potential damaged packaging.

    Product
    ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-04-07

    DePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage

    DePuy Orthopaedics is recalling specific lots of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System because of potential damaged packaging.

    Product
    The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Distribution
    39 states