Home / Recalls / Aesculap Implant Systems LLC / Z-2515-2021

Z-2515-2021 Class II Terminated

Recalled by Aesculap Implant Systems LLC — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
September 29, 2021
Initiation Date
March 19, 2021
Termination Date
March 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189Z AS UNIVATION XF FEMUR CEMENTED F5 LM

Reason for Recall

Malfunction- loosening of the implant resulting in a potential revision surgery

Distribution Pattern

US Nationwide distribution.

Code Information

All lots

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-1405-2022 Class II — RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. (June 30, 2021)
  • Z-1406-2022 Class II — LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. (June 30, 2021)
  • Z-2578-2021 Class II — PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU (April 16, 2021)