FDAFDA · Food and drugs·Recall number Z-0102-2018
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Published November 22, 2017 · Recall initiated: February 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- OH, MI and TX
- Lot
- Serial #s; RO10009, RO10011, RO10014, and RO13023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.