Recall Z-0496-2020— Teleflex Medical

Name: FDA recall Z-0496-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-04

Class II · Ongoing

Class II FDA medical device recall by Teleflex Medical, initiated 2019-10-04. It names one FDA 510(k) clearance: K152084. Product: WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. Reason: Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed)..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Ongoing
Initiated: 2019-10-04
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K152084 — Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugCorentec Co., Ltd.·cleared 2016-04-29

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

WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Reason for recall

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

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