Aesculap Recalls

Hazard: There is the potential for the length of the trocar shaft to be too long.

Hazard: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Hazard: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Hazard: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Hazard: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.

Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.

Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.

Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.

Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.

Hazard: The sterile blister packaging may be damaged, and sterility may be compromised.

Hazard: Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.

Hazard: Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.

Hazard: Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.

Hazard: AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier

Hazard: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

Hazard: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

Hazard: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

Hazard: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

Hazard: A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.

Hazard: Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).

Hazard: Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.

Hazard: Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.

Hazard: Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.

Hazard: AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.