Recall Z-0639-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0639-2018
Creator: U.S. Food and Drug Administration
Published: 2017-05-01

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-05-01, terminated 2020-07-13. It names one FDA 510(k) clearance: K151511. Product: ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.. Reason: Robot arm being sent to the wrong position.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Terminated: 2020-07-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K151511 — ROSA SpineMedtech S.A·cleared 2016-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.

Reason for recall

Robot arm being sent to the wrong position

Data sourced from openFDA. This site is unofficial and independent of the FDA.