FDAFDA · Food and drugs·Recall number Z-0160-2018
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Published November 29, 2017 · Recall initiated: November 6, 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
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US distribution in AR, GA, OH, MI, and TX.
- Lot
- Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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