The Recall Desk

FDA (Devices) recall action 83024

Zimmer Biomet, Inc. recalled 3 products on 2019-07-10

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
2019-07-10
Critical
0
Units
9,066

Why these products were recalled

There is a potential for weak seals of the sterile packaging.

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

1–3 of 3

  • ModerateFDA (Devices)··2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk

    Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.

    Product
    DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Distribution
    35 states
  • ModerateFDA (Devices)··2019-07-10

    Zimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues

    Zimmer Biomet is recalling K-Wire Trochar Tips because the sterile packaging may have weak seals, potentially compromising the device's sterility.

    Product
    K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Distribution
    35 states
  • ModerateFDA (Devices)··2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Depth Gauges for Packaging Defects

    Zimmer Biomet is recalling DVR Crosslock ePAK Depth Gauges due to a potential for weak seals in the sterile packaging.

    Product
    DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Distribution
    35 states