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Recall Observatory FDA recall evidence

Device product

DS Titanium Ligation Clip, used in laparoscopic surgery

Z-1290-2018

January 22, 2018

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 79530
Status
Terminated
Classification
Class II
Quantity
9621
Official record key
device-enforcement:Z-1290-2018

Official wording

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.

Code information: 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)

Distribution pattern: US and Canada distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.