Overview of recall records associated with Aesculap Implant Systems LLC, including dates, categories and classifications where available.
Classification mix: Class II: 44.
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.
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.
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
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.
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
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.
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.
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.
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.
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…
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.
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.
Packaging seal integrity not validated resulting in a lack of sterility assurance.
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
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
This page summarizes recall records in which the official source identifies Aesculap Implant Systems LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
