FDA Device Recalls

Class IIITerminated

END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

Neoprobe GDS Control Unit, Model Number NPCU3

Albumin Gen.2, Catalog 05166861190

Tina-quant Complement C4 ver.2, Catalog 05991994190