Aesculap Implant Systems LLC
39 recalls on record · Latest: Sep 7, 2022
FDA Devices Moderate Sep 7, 2022
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral sp…
FDA Devices Moderate Aug 17, 2022
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Devices Moderate Aug 10, 2022
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
FDA Devices Moderate Aug 10, 2022
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
FDA Devices Moderate Jul 27, 2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Devices Moderate Jul 27, 2022
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
FDA Devices Moderate Jul 27, 2022
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COM…
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA …
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL C…
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR …
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COM…
FDA Devices Moderate Mar 25, 2020
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K…
FDA Devices Moderate Mar 25, 2020
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476…
FDA Devices Moderate Mar 25, 2020
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088…
FDA Devices Moderate Mar 25, 2020
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN07…
FDA Devices Moderate Mar 25, 2020
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR0…
FDA Devices Moderate Sep 18, 2019
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where…
FDA Devices Low Apr 18, 2018
Strauss Penis Clamp 130MM/General Instruments
FDA Devices Low Apr 18, 2018
Doyen-Collin Mouth Gag 120MM/ General Instruments
FDA Devices Moderate Apr 11, 2018
DS Titanium Ligation Clip, used in laparoscopic surgery
FDA Devices Moderate Mar 7, 2018
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
FDA Devices Moderate Feb 21, 2018
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER…
FDA Devices Moderate Feb 21, 2018
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 …
FDA Devices Moderate Feb 21, 2018
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
FDA Devices Moderate Feb 21, 2018
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega K…
FDA Devices Moderate May 24, 2017
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.…
FDA Devices Moderate May 24, 2017
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0;…
FDA Devices Moderate May 24, 2017
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,…
FDA Devices Moderate Apr 19, 2017
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures withi…
FDA Devices Moderate Feb 22, 2017
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
FDA Devices Moderate Nov 2, 2016
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Devices Moderate Sep 19, 2012
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/ant…
FDA Devices Moderate Aug 8, 2012
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems…
FDA Devices Moderate Jul 11, 2012