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Terminated

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

FDA Recall Z-0184-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2014-09-05
Date Terminated2020-06-09
Product Quantity29 (8 US and 21 OUS)

Reason for Recall

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

Firm Action

This is a retrospective report of a correction initiated on 05-Sept-2014. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. There were 8 affected devices at customer sites in the US. Field Service Technicians were deployed to the consignee locations to perform the system upgrade.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution to AK, OH, TX, GA, and MI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101791ROSA SURGICAL DEVICEMedtech S.A.S · 2010-09-23K092239ROSA SURGICAL DEVICE, MODEL ROSA 1.1Medtech S.A · 2009-11-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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