Aesculap Implant Systems Llc
Center Valley, PA
This page shows every FDA and USDA recall linked to Aesculap Implant Systems Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
61
Total Recalls
2012
First Recall
2023
Most Recent
For intraventricular indications mainly used for operations within the brain ventricles.
Product Code: FF399R
Sep 6, 2023
· Device
Open, Classified
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable
Article Numb...
Jul 14, 2023
· Device
Open, Classified
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagula...
May 5, 2023
· Device
Open, Classified
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full...
Apr 25, 2023
· Device
Open, Classified
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilizatio...
Jul 15, 2022
· Device
Open, Classified
Aeos Robotic Digital Microscope with software versions 2.7 or earlier
Article Number: PV010
Jul 14, 2022
· Device
Terminated
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Oct 25, 2021
· Device
Terminated
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Jun 30, 2021
· Device
Terminated
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Jun 30, 2021
· Device
Terminated
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Catalog Number: FC700SU
Apr 16, 2021
· Device
Terminated
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US
Catalog Number: FG-000001-13
Apr 16, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NO156Z AS UNIVATION XF TIBIA CEMENTED...
Mar 19, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NL494 UNIVATION F MENISCAL COMP.T1 RM/...
Mar 19, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NL476 UNIVATION F MENISCAL COMP.T1 RM/...
Mar 19, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NL482 UNIVATION F MENISCAL COMP.T1 RM/...
Mar 19, 2021
· Device
Terminated
Univation X System Tray Sysem knee implant devices as follows:
Tray Number/Set Name/Set Number
NM1090R Navi...
Mar 19, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NO180Z AS UNIVATION XF FEMUR CEMENTED...
Mar 19, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NL470 UNIVATION F MENISCAL COMP.T1 RM/...
Mar 19, 2021
· Device
Terminated
Univation X System knee implant devices as follows:
Catalog/Product:
NL488 UNIVATION F MENISCAL COMP.T1 RM/...
Mar 19, 2021
· Device
Terminated
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Feb 19, 2021
· Device
Completed
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Nov 18, 2020
· Device
Terminated
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Us...
Sep 8, 2020
· Device
Terminated
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in sp...
Sep 8, 2020
· Device
Terminated
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal...
Sep 8, 2020
· Device
Terminated
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Us...
Sep 8, 2020
· Device
Terminated
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spi...
Sep 8, 2020
· Device
Terminated
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spin...
Sep 8, 2020
· Device
Terminated
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Jul 13, 2020
· Device
Terminated
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Apr 1, 2020
· Device
Completed
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Apr 1, 2020
· Device
Completed
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos.
NN058Z
NN070Z
NN071Z
N...
Jan 21, 2020
· Device
Terminated
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos.
NN081K
NN082K
NN083K
NN...
Jan 21, 2020
· Device
Terminated
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K
NN070K
NN071K
NN...
Jan 21, 2020
· Device
Terminated
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos.
NN469K
NN470K
NN471K
NN...
Jan 21, 2020
· Device
Terminated
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.
NR068K
NR068Z
NR070K...
Jan 21, 2020
· Device
Terminated
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument u...
Nov 12, 2019
· Device
Completed
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping u...
Oct 1, 2019
· Device
Terminated
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to g...
Sep 25, 2019
· Device
Terminated
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
REF: PL730SU - Product Usage: Instrument intended for use in general su...
Aug 7, 2019
· Device
Terminated
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM
REF: PL731SU- Product Usage: Instrument intended for use in general sur...
Aug 7, 2019
· Device
Terminated
Strauss Penis Clamp 130MM/General Instruments
Feb 16, 2018
· Device
Terminated
Doyen-Collin Mouth Gag 120MM/ General Instruments
Feb 16, 2018
· Device
Terminated
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT,...
Feb 15, 2018
· Device
Terminated
JS Series SterilContainer S2 System
Feb 15, 2018
· Device
Terminated
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468)
The af...
Feb 12, 2018
· Device
Terminated
DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Jan 22, 2018
· Device
Terminated
DS Titanium Ligation Clip, used in laparoscopic surgery
Jan 22, 2018
· Device
Terminated
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System
Shunt, central nervous system and...
Sep 21, 2017
· Device
Terminated
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+...
Sep 5, 2017
· Device
Terminated
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5
ELAN 4 1-RING TWIST DRILL D2.0
ELAN 4 2-RING TWIST DRILL D1,0/4,0...
Sep 5, 2017
· Device
Terminated