Recall Z-0116-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0116-2018
Creator: U.S. Food and Drug Administration
Published: 2016-07-29

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-07-29, terminated 2020-06-16. It names one FDA 510(k) clearance: K151359. Product: ROSA BRAIN 3.0.0. Reason: Non-conforming product label..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-29
Terminated: 2020-06-16
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K151359 — ROSA BrainMedtech S.A·cleared 2015-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ROSA BRAIN 3.0.0

Reason for recall

Non-conforming product label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.