The Recall Desk

FDA (Devices) recall action 76820

Zimmer Biomet, Inc. recalled 2 products on 2017-04-19

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
2017-04-19
Critical
0
Units
17

Why these products were recalled

Unapproved change made by the supplier.

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)··2017-04-19

    Zimmer Biomet Recalls MEDTECH ROSA Spine Software Due to Unapproved Change

    Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.

    Product
    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed w
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2017-04-19

    Zimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.

    Product
    MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is in
    Category
    Distribution
    11 states