Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0099-2018)

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: February 5, 2013

Date Posted: November 22, 2017

Recall Number: Z-0099-2018

Event ID: 77662

Reason for Recall:

Observed instability of the device.

Status: Terminated

Product Quantity: 53 units

Code Information:

Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15058, RO15059, RO15061, RO15063, RO15064, and RO15069

Distribution Pattern:

Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX

Voluntary or Mandated:

Voluntary: Firm initiated