The Recall Desk

FDA (Devices) recall action 73363

Zimmer Spine, Inc. recalled 2 products on 2016-03-30

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
2016-03-30
Critical
0
Units
5,990

Why these products were recalled

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).

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)··2016-03-30

    Zimmer Spine Universal Clamp System Recall for Updated Cleaning Instructions

    Zimmer Spine is issuing a correction notice for the Universal Clamp System to provide updated cleaning and disinfecting instructions.

    Product
    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2016-03-30

    Zimmer Biomet Issues Correction Notice for Instinct Java System Cleaning Instructions

    Zimmer Biomet is issuing a correction notice to provide updated cleaning and disinfecting instructions for the Instinct Java System and Universal Clamp System.

    Product
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
    Category
    Distribution
    28 states