The Recall Desk

FDA (Devices) recall action 65502

Zimmer, Inc. recalled 2 products on 2013-08-21

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
2013-08-21
Critical
0
Units
6,326

Why these products were recalled

There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab 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.

1–2 of 2

  • HighFDA (Devices)··2013-08-21

    Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.

    Product
    REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-08-21

    Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.

    Product
    REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact
    Category
    Distribution
    0 states