Recall Z-0105-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0105-2018
Creator: U.S. Food and Drug Administration
Published: 2016-05-27

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-05-27, terminated 2020-06-16. It names one FDA 510(k) clearance: K101791. 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.. Reason: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-27
Terminated: 2020-06-16
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K101791 — ROSA SURGICAL DEVICEMedtech S.A.S·cleared 2010-09-23

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 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.

Reason for recall

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

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