Recall Z-0184-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0184-2018
Creator: U.S. Food and Drug Administration
Published: 2014-09-05

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2014-09-05, terminated 2020-06-09. It names 2 FDA 510(k) clearances: K101791, K092239. 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. Reason: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-05
Terminated: 2020-06-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K101791 — ROSA SURGICAL DEVICEMedtech S.A.S·cleared 2010-09-23
K092239 — ROSA SURGICAL DEVICE, MODEL ROSA 1.1Medtech S.A·cleared 2009-11-17

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 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

Reason for recall

The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.

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