—#157798

Product

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K101791
Affected lot / code info: Serial No. BR16004, BR15002, and BR15003

Why it was recalled

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (DC) and Internationally to Australia and France.

Timeline

Recall initiated: 2016-05-27
Terminated: 2020-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157798. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.