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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-0100-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2012-04-19
Date Terminated2020-06-16
Product Quantity14 units

Reason for Recall

Potential failure of the optical distance sensor due to cable disconnection.

Firm Action

Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected customers. Customers were informed on site of the device correction by Field Service Technicians. For questions regarding this recall call 574-267-6131.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy

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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