Home / Recalls / Aesculap Implant Systems LLC / Z-1446-2022

Z-1446-2022 Class II Terminated

Recalled by Aesculap Implant Systems LLC — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
September 8, 2020
Termination Date
April 10, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23

Product Description

AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.

Reason for Recall

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Distribution Pattern

United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.

Code Information

UDI-DI: 04038653362325

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-2578-2021 Class II — PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU (April 16, 2021)