Recall Z-2284-2016— LeMaitre Vascular, Inc.

Name: FDA recall Z-2284-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-22

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2016-06-22, terminated 2021-04-08. It names one FDA 510(k) clearance: K962043. Product: 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.. 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..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Terminated: 2021-04-08
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K962043 — AUTO SUTURE MODIFIED VCS CLIP APPLIERUnited States Surgical, A Division of Tyco Healthc·cleared 1996-09-23

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

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.

Reason for recall

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.

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