FDA recall Z-1291-2018

Aesculap Implant Systems LLC · Class II · device

Product

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.

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-1291-2018