Recall Z-0178-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0178-2018
Creator: U.S. Food and Drug Administration
Published: 2013-02-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2013-02-10, terminated 2020-06-09. It names 2 FDA 510(k) clearances: K101791, K092239. Product: ROSA Surgical Device 2.5.8. Reason: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-10
Terminated: 2020-06-09
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

Reason for recall

Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.

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