Recall Z-1291-2018— Aesculap Implant Systems LLC

Name: FDA recall Z-1291-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-22

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2018-01-22, terminated 2019-09-24. It names 2 FDA 510(k) clearances: K102081, K080753. Product: DS Titanium Ligation Clip Appliers, used in laparoscopic surgery. Reason: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2018-01-22
Terminated: 2019-09-24
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K102081 — ENDOSCOPIC CLIP SYSTEMAesculap, Inc.·cleared 2010-08-06
K080753 — AESCULAP ENDOSCOPIC CLIP SYTEMAesculap, Inc.·cleared 2008-04-02

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

DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

Reason for recall

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

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