1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
American Contract Systems
Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Smart Toe II Intramedullary Arthrodesis Implant
Stryker GmbH
Class I - Dangerous
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
St. Jude Medical, Cardiac Rhythm Management Division
Class I - Dangerous
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
St. Jude Medical, Cardiac Rhythm Management Division
Class I - Dangerous
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Class I - Dangerous
There is potential for the capsule bond to break during the procedure.
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
St. Jude Medical, Cardiac Rhythm Management Division
Class I - Dangerous
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Conformis
Class I - Dangerous
Incorrect tibial base plate implant packaged in kit
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Stradis Medical, LLC
Class I - Dangerous
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare
Class I - Dangerous
Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.
Anterior Hip Pack - Surgical Kit
Stradis Medical, LLC
Class I - Dangerous
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Total Knee Pack - Surgical Kit
Stradis Medical, LLC
Class I - Dangerous
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Class I - Dangerous
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Class I - Dangerous
Products are mislabeled with the incorrect product identification on individual kit labeling.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Class I - Dangerous
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.