Implants & Prosthetics

Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Misprinted IFUs shipped with esophageal stents

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The lot contained two outer pins instead of one outer and one inner pin.

Incomplete seals on the sterile package may compromise the sterility

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility