Recall Z-0496-2020 ยท FZP Clip, Implantable
Teleflex Medical
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
| Date | Oct 4, 2019 |
| Status | Open, Classified |
| 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). |
| Root cause | Under Investigation by 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. |
| Quantity | 34491 devices |
| Distribution | Worldwide distribution, including US nationwide (including Puerto Rico). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug Corentec Co., Ltd., Apr 29, 2016 |