Z-1291-2018Class II

DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

Name: Z-1291-2018 DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Creator: Aesculap Implant Systems LLC
Published: 2018-01-22
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2018-01-22 / Terminated / root cause: labeling and UDI

FDA source

Aesculap Implant Systems LLC began a recall of DS Titanium Ligation Clip Appliers, used in laparoscopic surgery on 2018-01-22. FDA classified it as Class II and gives the reason as "Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1291-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-22
Posted: 2018-04-02
Terminated: 2019-09-24
Recalling firm: Aesculap Inc
Product: DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Product code: FZP Clip, Implantable
Reason for recall: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Root cause tag: labeling and UDI
FDA root cause: 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: 270
Distribution: US and Canada distribution
Product codes and lots: DS Clip Appliers - Product Numbers PL808R DS SINGLE FIRE LAP.APPLIER L 12/310MM PL802R DS SINGLE FIRE LAP.APPLIER SM 5/310MM PL826R DS SINGLE FIRE LAP.APPLIER M 10/420MM PL817R DS SINGLE FIRE LAP.REM.FORC.ML 10/310MM PL828R DS SINGLE FIRE LAP.APPLIER L 12/420MM PL809R DS SINGLE FIRE LAP.APPLIER XL 12/310MM PL806R DS SINGLE FIRE LAP.APPLIER M 10/310MM PL818R DS SINGLE FIRE LAP.REM.FORC.L 12/310MM PL801R DS SINGLE FIRE LAP.APPLIER S 5/310MM PL816R DS SINGLE FIRE LAP.REM.FORC.M 10/310MM PL807R DS SINGLE FIRE LAP.APPLIER ML 10/310MM PL822R DS SINGLE FIRE LAP.APPLIER SM 5/420MM PL827R DS SINGLE FIRE LAP.APPLIER ML 10/420MM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1291-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1290-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1291-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02

Product code FZP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)