Date Initiated by Firm |
January 22, 2018 |
Create Date |
April 02, 2018 |
Recall Status1 |
Terminated 3 on September 24, 2019 |
Recall Number |
Z-1290-2018 |
Recall Event ID |
79530 |
510(K)Number |
K102081 K080753
|
Product Classification |
Clip, implantable - Product Code FZP
|
Product |
DS Titanium Ligation Clip, used in laparoscopic surgery |
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) |
Recalling Firm/ Manufacturer |
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
|
For Additional Information Contact |
Val Strawn 610-984-9414
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Labeling design |
Action |
A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned.
IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use. |
Quantity in Commerce |
9621 |
Distribution |
US and Canada distribution |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FZP and Original Applicant = AESCULAP, INC.
|