Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0105-2018)

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 Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

Product Classification:

Class II

Date Initiated: May 27, 2016

Date Posted: November 29, 2017

Recall Number: Z-0105-2018

Event ID: 77742

Reason for Recall:

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial No. BR16004, BR15002, and BR15003

Distribution Pattern:

Worldwide Distribution - US (DC) and Internationally to Australia and France.

Voluntary or Mandated:

Voluntary: Firm initiated