Z-1291-2018 Class II Terminated
FDA device recall Z-1291-2018 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. Updated cleaning and sterilization instructions. The recall status is terminated (terminated Sep 24, 2019). Affected quantity: 270.
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
- 270
Product Description
DS Titanium Ligation Clip Appliers, 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. Updated cleaning and sterilization instructions.
Distribution Pattern
US and Canada distribution
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1291-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026