American Medical Systems, Inc. is initiating a recall on two components of the AMS 800Âŋ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Presource PBDS, Knee Arthroscopy, Kit, Circulator
Cardinal Health, Medical Products & Services
Class I - Dangerous
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Presource PBDS, Total Hip, Kit, Circulator
Cardinal Health, Medical Products & Services
Class I - Dangerous
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
DePuy Mitek, Inc., a Johnson & Johnson
Class I - Dangerous
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Presource PBDS, Total Joint, Kit, Circulator
Cardinal Health, Medical Products & Services
Class I - Dangerous
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Presource PBDS, Total Knee, Kit, Circulator
Cardinal Health, Medical Products & Services
Class I - Dangerous
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Class I - Dangerous
The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.
Presource PBDS, Knee Arthroscopy, Kit, Circulator
Cardinal Health, Medical Products & Services
Class I - Dangerous
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Class I - Dangerous
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Class I - Dangerous
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Encore Medical
Class I - Dangerous
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.
Class I - Dangerous
Sterile packaging may be compromised.
Class I - Dangerous
Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Class I - Dangerous
With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.
Class I - Dangerous
Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor conti
GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
Class I - Dangerous
Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.