Implants & Prosthetics

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.