Home / Recalls / Aesculap Implant Systems LLC / Z-1291-2018

Z-1291-2018 Class II Terminated

Recalled by Aesculap Implant Systems LLC — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
January 22, 2018
Termination Date
September 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

Other recalls by Aesculap Implant Systems LLC

  • Z-2518-2023 Class II — For intraventricular indications mainly used for operations within the brain ven (July 20, 2023)
  • Z-2146-2023 Class II — Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non- (May 18, 2023)
  • Z-1569-2023 Class II — Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulati (March 21, 2023)
  • Z-1430-2023 Class II — Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervic (February 23, 2023)
  • Z-1638-2022 Class II — Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental a (July 15, 2022)
  • Z-1516-2022 Class II — Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article (July 14, 2022)
  • Z-1410-2022 Class II — MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Inst (October 25, 2021)
  • Z-1406-2022 Class II — LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. (June 30, 2021)
  • Z-1405-2022 Class II — RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. (June 30, 2021)
  • Z-2579-2021 Class II — PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 (April 16, 2021)