DS Titanium Ligation Clip, used in laparoscopic surgery
Reported: April 11, 2018 Initiated: January 22, 2018 #Z-1290-2018
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.
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Units Affected
- 9621
- Distribution
- US and Canada distribution
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
DS Titanium Ligation Clip, used in laparoscopic surgery. Recalled by Aesculap Implant Systems LLC. Units affected: 9621.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1290-2018.
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