Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0638-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.

Product Classification:

Class II

Date Initiated: May 1, 2017

Date Posted: February 28, 2018

Recall Number: Z-0638-2018

Event ID: 78944

Reason for Recall:

Robot arm being sent to the wrong position

Status: Terminated

Product Quantity: 16

Code Information:

BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025.

Distribution Pattern:

Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated