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Open, Classified

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

FDA Recall Z-0496-2020 · Posted None

Recalling FirmTeleflex Medical
Recall StatusOpen, Classified
Product CodeFZP
Date Initiated2019-10-04
Product Quantity34491 devices

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).

Firm Action

The firm notified their consignees by letter on 10/04/2019. The letter explained the issue and requested the user discontinue use and contact the company for instructions for their return. Distributors were directed to notify their customers and collect the affected product for return to Teleflex Medical.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution, including US nationwide (including Puerto Rico).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugCorentec Co., Ltd. · 2016-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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