FDA recall Z-1290-2018

Product

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.

Distribution

US and Canada distribution

Key facts

Status

Terminated

Initiation date

2018-01-22

Report date

2018-04-11

Termination date

2019-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1290-2018