The Recall Desk

FDA (Devices) recall action 83085

Zimmer Biomet, Inc. recalled 2 products on 2019-07-24

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
2019-07-24
Critical
0
Units
16,956

Why these products were recalled

The products do not have sufficient data to support the labeled shelf life of 10 years.

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

  • ModerateFDA (Devices)··2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Hose/Drape Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Hose/Drape Assemblies because there is insufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Irrigation Tubing Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Distribution
    0 states