Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0102-2018)

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. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

Product Classification:

Class II

Date Initiated: February 14, 2014

Date Posted: November 22, 2017

Recall Number: Z-0102-2018

Event ID: 78372

Reason for Recall:

An undetected shift between the information displayed in the navigation software and the actual patient anatomy

Status: Terminated

Product Quantity: 21 (4 US and 17 OUS)

Code Information:

Serial #s; RO10009, RO10011, RO10014, and RO13023

Distribution Pattern:

OH, MI and TX

Voluntary or Mandated:

Voluntary: Firm initiated