Recall Z-0115-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0115-2018
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-04-08, terminated 2020-07-13. It names one FDA 510(k) clearance: K101791. Product: ROSA Surgical Device 2.5.8. Reason: Potential for software to change the final tool orientation for the command position without command..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Terminated: 2020-07-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K101791 — ROSA SURGICAL DEVICEMedtech S.A.S·cleared 2010-09-23

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

Reason for recall

Potential for software to change the final tool orientation for the command position without command.

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