Class I - Dangerous
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.
Aesculap Implant Systems
62 recalls • • Categories: Other Medical Devices, Surgical Instruments, Implants & Prosthetics, Infusion Pumps
Class I - Dangerous
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
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.
Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
Class I - Dangerous
Potential for the incorrect screw to be included in the package.
Class I - Dangerous
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Class I - Dangerous
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.
Class I - Dangerous
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Class I - Dangerous
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Class I - Dangerous
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.
Class I - Dangerous
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
Class I - Dangerous
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.
Class I - Dangerous
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Class I - Dangerous
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Class I - Dangerous
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
Class I - Dangerous
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
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Malfunction- loosening of the implant resulting in a potential revision surgery
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
possibility of the sterility batch being insufficiently sterilized
possibility of the sterility batch being insufficiently sterilized
Class I - Dangerous
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Class I - Dangerous
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Class I - Dangerous
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.
Class I - Dangerous
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Class I - Dangerous
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Class I - Dangerous
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Class I - Dangerous
The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
Class I - Dangerous
Generators may have a faulty component which could impact the proper functioning of the device.
Class I - Dangerous
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Class I - Dangerous
There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.
There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree tria
Class I - Dangerous
Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.