FDA Device

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

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 You Should Do

Remedy

All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.

Products

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Brand
Zimmer Biomet, Inc.
UPC
Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.

Units Affected

31 units