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Terminated

DS Titanium Ligation Clip, used in laparoscopic surgery

FDA Recall Z-1290-2018 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeFZP
Date Initiated2018-01-22
Date Terminated2019-09-24
Product Quantity9621

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

US and Canada distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102081ENDOSCOPIC CLIP SYSTEMAesculap, Inc. · 2010-08-06K080753AESCULAP ENDOSCOPIC CLIP SYTEMAesculap, Inc. · 2008-04-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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