The Recall Desk

FDA (Devices) recall action 81758

Zimmer Biomet, Inc. recalled 2 products on 2019-01-23

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
2019-01-23
Critical
0
Units
1,942

Why these products were recalled

There is a potential for silicone shedding during cleaning and sterilization.

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)··2019-01-23

    Zimmer Biomet Recalls Maximum Variable Pitch Compression Screw Caddy

    Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Screw Caddies due to a potential for silicone shedding during cleaning and sterilization.

    Product
    Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-01-23

    Zimmer Biomet Recalls Compression Tray Bases Due to Silicone Shedding

    Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Tray Bases because they may shed silicone during cleaning and sterilization.

    Product
    Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
    Category
    Distribution
    0 states