Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip, used in laparoscopic surgery

Recall date

January 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1290-2018

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

US and Canada distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DS Titanium Ligation Clip, used in laparoscopic surgery