FDAFDA · Food and drugs·Recall number Z-0178-2018
ROSA Surgical Device 2.5.8
Published December 6, 2017 · Recall initiated: February 10, 2013
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
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- AR, OH, MI, and TX
- Lot
- Serial No. RO10011, RO10014, RO13023 and RO13027
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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