Recall Z-0134-2017— ConMed Corporation

Name: FDA recall Z-0134-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-27

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2016-06-27, terminated 2018-06-07. It names one FDA 510(k) clearance: K926477. Product: CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures. Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product..

Recalling firm: ConMed Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Terminated: 2018-06-07
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K926477 — BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTOCore Dynamics, Inc.·cleared 1993-11-12

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

CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

Reason for recall

The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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