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Aesculap Implant Systems Recalls
62 recalls on record · June 20, 2012 to September 13, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 13, 2023Medical DevicesFDA
Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Hazard: Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
July 26, 2023Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Hazard: Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
May 17, 2023Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablat
Hazard: Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
May 3, 2023Medical DevicesFDA
Aesculap Implant Systems LLC recalls Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System -
Hazard: Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
September 7, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the l
Hazard: Potential for the incorrect screw to be included in the package.
August 17, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Hazard: Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
August 10, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Hazard: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
August 10, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Hazard: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, produ
Hazard: Packaging seal integrity not validated resulting in a lack of sterility assurance.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spin
Hazard: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spin
Hazard: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion sur
Hazard: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion
Hazard: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusio
Hazard: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion
Hazard: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Hazard: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Hazard: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Hazard: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Hazard: Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Hazard: Customized coronal rod benders may deform the implant when used with the spinal system devices.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Hazard: Customized coronal rod benders may deform the implant when used with the spinal system devices.
July 27, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during
Hazard: Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
July 20, 2022Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a sut
Hazard: Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
October 6, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Hazard: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
October 6, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Hazard: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; N
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; N
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM;
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM;
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery