Recall Z-2284-2016 ยท FZP Clip, Implantable
LeMaitre Vascular, Inc.
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
| Date | Jun 22, 2016 |
| Status | Terminated |
| Reason | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the r |
| Quantity | 471 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962043 | AUTO SUTURE MODIFIED VCS CLIP APPLIER United States Surgical, A Division of Tyco Healthc, Sep 23, 1996 |