Recall Z-1453-2015— US Endoscopy Group Inc

Name: FDA recall Z-1453-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-10

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2015-03-10, terminated 2016-10-27. It names one FDA 510(k) clearance: K962676. Product: Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.. Reason: A wire component on the distal grasping assembly of the device became detached...

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-10
Terminated: 2016-10-27
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.·cleared 1996-10-04

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

Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

Reason for recall

A wire component on the distal grasping assembly of the device became detached..

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