The Recall Desk

FDA (Devices) recall action 70043

DePuy Orthopaedics, Inc. recalled 3 products on 2015-01-14

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
2015-01-14
Critical
0
Units
13,077

Why these products were recalled

ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.

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

1–3 of 3

  • SevereFDA (Devices)··2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.

    Product
    Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home…
    Category
    Distribution
    2 states