Recall Z-0160-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0160-2018
Creator: U.S. Food and Drug Administration
Published: 2014-11-06

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2014-11-06, terminated 2020-07-13. It names 2 FDA 510(k) clearances: K101791, K092239. Product: ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.. Reason: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended)..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-06
Terminated: 2020-07-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K101791 — ROSA SURGICAL DEVICEMedtech S.A.S·cleared 2010-09-23
K092239 — ROSA SURGICAL DEVICE, MODEL ROSA 1.1Medtech S.A·cleared 2009-11-17

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 Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

Reason for recall

Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

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