Recall Z-1290-2018— Aesculap Implant Systems LLC

Name: FDA recall Z-1290-2018
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, used in laparoscopic surgery. Reason: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm..

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, 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. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.

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