Aesculap Implant Systems LLC

FDA Regulatory Profile

Summary

Total Recalls
62
510(k) Clearances
51
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2518-2023Class IIFor intraventricular indications mainly used for operations within the brain ventricles. Product CoJuly 20, 2023
Z-2146-2023Class IIAesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable AMay 18, 2023
Z-1569-2023Class IIAesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cuttiMarch 21, 2023
Z-1430-2023Class IICaspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) BFebruary 23, 2023
Z-1638-2022Class IIAesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stJuly 15, 2022
Z-1516-2022Class IIAeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010July 14, 2022
Z-1410-2022Class IIMODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441October 25, 2021
Z-1405-2022Class IIRIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.June 30, 2021
Z-1406-2022Class IILEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.June 30, 2021
Z-2578-2021Class IIPAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUApril 16, 2021
Z-2579-2021Class IIPAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13April 16, 2021
Z-2514-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIMarch 19, 2021
Z-2516-2021Class IIUnivation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NMMarch 19, 2021
Z-2515-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUMarch 19, 2021
Z-2513-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL CMarch 19, 2021
Z-2512-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL CMarch 19, 2021
Z-2509-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL CMarch 19, 2021
Z-2511-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL CMarch 19, 2021
Z-2510-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL CMarch 19, 2021
Z-1409-2022Class IIUniversal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010February 19, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K213871Ennovate Cervical Spinal and Occiput SystemJuly 1, 2022
K210963ENNOVATE Spinal SystemJuly 19, 2021
K180433ENNOVATE®April 26, 2018
K162134ENNOVATE Spinal SystemDecember 14, 2016
K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsJuly 8, 2016
K153629ArcadiusXP C Spinal SystemMay 25, 2016
K153396Aesculap OrthoPilot Next GenerationMay 16, 2016
K151938S4 Cervical Spinal and Occiput SystemsOctober 21, 2015
K151056Aesculap T-Space PEEK and XP Spinal SystemAugust 13, 2015
K150544Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemMay 29, 2015
K141694AESCULAP ORTHOPILOT NEXT GENERATIONFebruary 24, 2015
K150062Excia Total Hip SystemFebruary 9, 2015
K143106VEGA Knee SystemNovember 21, 2014
K140915EXCIA TOTAL HIP SYSTEMJuly 21, 2014
K140452VEGA KNEE SYSTEMMarch 25, 2014
K132421AESCULAP PEEK XP SPINAL IMPLANT SYSTEMJanuary 22, 2014
K131167UNIVATIONOctober 17, 2013
K123939S4 SPINAL SYSTEMMarch 12, 2013
K120955COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEMDecember 17, 2012
K123352S4 SPINAL SYSTEMDecember 12, 2012