The Recall Desk

FDA (Devices) recall action 82125

Zimmer Trabecular Metal Technology, Inc. recalled 2 products on 2019-03-20

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
2019-03-20
Critical
0
Units
50

Why these products were recalled

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

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

  • ModerateFDA (Devices)··2019-03-20

    Zimmer NexGen Trabecular Metal Tibial Augment Recall for Label Mismatch

    Zimmer Trabecular Metal Technology is recalling 24 units of NexGen Tibial Half Block Augments because the product in the box may not match the label.

    Product
    NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the kne
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2019-03-20

    FDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch

    Zimmer Trabecular Metal Technology is recalling 26 units of NexGen Trabecular Metal Tibial Half Block Augments because the product in the box may not match the label.

    Product
    NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the kne
    Category
    Distribution
    14 states