The Recall Desk

FDA (Devices) recall action 68390

Zimmer, Inc. recalled 3 products on 2014-07-16

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
2014-07-16
Critical
0
Units
2,654

Why these products were recalled

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

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.

1–3 of 3

  • HighFDA (Devices)··2014-07-16

    Zimmer Hip Joint Prosthesis Recalled for Black Residue in Sterile Pouches

    Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.

    Product
    Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary fo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-07-16

    Zimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue

    Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology because black residue was observed in the sterile pouches.

    Product
    Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary fo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-07-16

    Zimmer M/L Taper Hip Stem Recall Due to Black Residue

    Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.

    Product
    Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and
    Category
    Distribution
    0 states