medical Class III Updated 2020-11-11

Synthes (USA) Products LLC recalls END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product

Recalled Product

END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - 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.


Hazard / Issue

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

Issued by

FDA

Distribution: International distribution the country of Japan Only.
Lot/Code Info: Lot Numbers: 17P4887 32P3937
View official government recall

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