Aesculap Implant Systems recalls
16 official recalls and safety alerts involving Aesculap Implant Systems since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Aesculap Implant Systems or the relevant agency.
- 2023-09-13
USAesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
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.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.Official notice →- 2023-07-26
- US
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
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of DC, MO, PA, TX.Official notice → - 2023-05-17
- US
Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during…
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.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the state of OH.Official notice → - 2023-05-03
- US
Aesculap Implant Systems LLC recalls Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A…
Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.Official notice → - 2022-09-07
- US
Aesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar,…
Potential for the incorrect screw to be included in the package.
- 2022-08-17
- US
Aesculap Implant Systems LLC recalls Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
FDA · DeviceAesculap Implant Systems LLCUS Distribution to states of: AR, IN, NE and NCOfficial notice → - 2022-08-10
- US
Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - 2022-07-27
- US
Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code…
Packaging seal integrity not validated resulting in a lack of sterility assurance.
FDA · DeviceAesculap Implant Systems LLCUnited States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WIOfficial notice → - US
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
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.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC,…Official notice → - US
Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
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.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.Official notice → - US
Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
- US
Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
- US
Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Customized coronal rod benders may deform the implant when used with the spinal system devices.
- US
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 orthopedic…
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA,…Official notice → - 2022-07-20
- US
Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
- 2021-10-06
- US
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
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
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, MI, NY, TX, WI.Official notice →