Recalls / —

—#157797

Product

ROSA BRAIN 3.0.0

FDA product code

HAW — Neurological Stereotaxic Instrument

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K151359

Affected lot / code info

Serial No. BR16017 and BR16018

Why it was recalled

Non-conforming product label.

Root cause (FDA determination)

Error in labeling

Action the firm took

All affected devices received a corrected label. Correction notification and implementation were performed by field technicians.

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

OH and PA.

Timeline

Recall initiated

2016-07-29

Terminated

2020-06-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #157797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.