Home / Recalls / Aesculap Implant Systems LLC / Z-0809-2018

Z-0809-2018 Class II Terminated

Recalled by Aesculap Implant Systems LLC — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
September 21, 2017
Termination Date
August 8, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components

Reason for Recall

A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.

Distribution Pattern

US Distribution to PA.

Code Information

Batch #20034364 and #20034751

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)