Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0184-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 5, 2014

Date Posted: December 6, 2017

Recall Number: Z-0184-2018

Event ID: 78362

Reason for Recall:

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

Status: Terminated

Product Quantity: 29 (8 US and 21 OUS)

Code Information:

Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated