Class I - Dangerous
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
ðĶī
Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Class I - Dangerous
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.
Class I - Dangerous
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
Class I - Dangerous
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
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
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
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
Boston Scientific
Class I - Dangerous
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.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.