—#159343

Product

ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K092239, K101791
Affected lot / code info: Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035

Why it was recalled

The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.

Root cause (FDA determination)

Software design

Action the firm took

This is a retrospective report of a correction initiated on 05-Sept-2014. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. There were 8 affected devices at customer sites in the US. Field Service Technicians were deployed to the consignee locations to perform the system upgrade.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Nationwide Distribution to AK, OH, TX, GA, and MI

Timeline

Recall initiated: 2014-09-05
Terminated: 2020-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.