Aesculap Implant Systems LLC: Medical Device Recall in 2018 - (Recall #: Z-1290-2018)
See the recall detail below. You can also see other recalls from the same firm in 2018.
DS Titanium Ligation Clip, used in laparoscopic surgery
Class II
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.
DS Clips - Product Numbers PL450SU DS SINGLE FIRE LIG.CLIPS PL471SU DS SINGLE FIRE LIG.CLIP L W/LATCH PL453SU DS SINGLE FIRE LIG.CLIP SM PL475SU DS SINGLE FIRE LIG.CLIP XL W/LATCH PL459SU DS SINGLE FIRE LIG.CLIP M PL462SU DS SINGLE FIRE LIG.CLIP ML PL465SU DS SINGLE FIRE LIG.CLIP ML W/LATCH PL468SU DS SINGLE FIRE LIG.CLIP L (all clips going back 5 years)
US and Canada distribution
Voluntary: Firm initiated