Z-1290-2018 Class II Terminated
FDA device recall Z-1290-2018 was initiated by Aesculap Implant Systems LLC on Jan 22, 2018 and is designated Class II. 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… The recall status is terminated (terminated Sep 24, 2019). Affected quantity: 9621.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 11, 2018
- Initiation Date
- Jan 22, 2018
- Termination Date
- Sep 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9621
Product Description
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 Pattern
US and Canada distribution
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1290-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026