The Recall Desk

FDA (Devices) recall action 69366

Zimmer, Inc. recalled 2 products on 2014-12-03

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
2014-12-03
Critical
0
Units
6,126

Why these products were recalled

To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.

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)··2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads

    Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.

    Product
    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Distribution
    38 states
  • ModerateFDA (Devices)··2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints

    Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.

    Product
    Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Distribution
    38 states