Recall Z-3117-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-3117-2017
Creator: U.S. Food and Drug Administration
Published: 2016-01-20

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-01-20, terminated 2018-04-30. It names 2 FDA 510(k) clearances: K101791, K092239. Product: Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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: Complaints were received reporting the system would freeze/shut down while in Fulgurate mode..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-20
Terminated: 2018-04-30
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

Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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

Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.

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