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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-0096-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2013-12-18
Date Terminated2020-06-29
Product Quantity21 units total

Reason for Recall

Possible break in the connector of the Force Sensor.

Firm Action

Customers were informed onsite by Field Service Technicians of the planned correction.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution to OH, MI, and TX

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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