—#157387

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 No. RO10011 and RO10014

Why it was recalled

Potential failure of the optical distance sensor due to cable disconnection.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected customers. Customers were informed on site of the device correction by Field Service Technicians. For questions regarding this recall call 574-267-6131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy

Timeline

Recall initiated: 2012-04-19
Terminated: 2020-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157387. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.