Home / Recalls / Aesculap Implant Systems LLC / Z-1383-2022

Z-1383-2022 Class II Terminated

Recalled by Aesculap Implant Systems LLC — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
July 20, 2022
Initiation Date
September 25, 2019
Termination Date
April 1, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 pieces

Product Description

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

Reason for Recall

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

Distribution Pattern

United States: TX and AK

Code Information

UDI-DI (GTIN): 04046955063277

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)