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Terminated

ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

FDA Recall Z-2868-2017 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2016-10-11
Date Terminated2020-06-29
Product Quantity20 units (16 US, 4 OUS)

Reason for Recall

Complaint of the head holder connector locking up mechanically when tightened.

Firm Action

Product was/will be corrected by Field Technician staff in the form of a visit.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France

Official Source

View FDA Recall →

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

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