Recall Z-0437-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-0437-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-03

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2014-11-03, terminated 2015-02-03. It names one FDA 510(k) clearance: K131861. Product: 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.. Reason: Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Terminated: 2015-02-03
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

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

8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Reason for recall

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

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