The Recall Desk

FDA (Devices) recall action 66717

Zimmer, Inc. recalled 3 products on 2013-12-18

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
2013-12-18
Critical
0
Units
—

Why these products were recalled

As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media

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

1–3 of 3

  • HighFDA (Devices)··2013-12-18

    Zimmer Total Ankle Components Recalled for Manufacturing Residue

    Zimmer, Inc. is recalling specific Total Ankle Talar Components due to potential elevated levels of manufacturing residue on the implants.

    Product
    Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-12-18

    Zimmer Trabecular Metal Total Ankle Tibial Base Component Recall

    Zimmer, Inc. is recalling specific sizes of the Trabecular Metal Total Ankle Tibial Base Component due to potential elevated levels of manufacturing residue.

    Product
    Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-18

    Zimmer Trabecular Metal Total Ankle Talar Component Recall for Residue

    Zimmer, Inc. is recalling specific Total Ankle Talar Components because routine monitoring found potential elevated levels of manufacturing residue on the implants.

    Product
    Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular M
    Category
    Distribution
    0 states