PlainRecalls
FDA Devices Low Class III Terminated

END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - 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.

Reported: November 11, 2020 Initiated: September 21, 2020 #Z-0410-2021

Product Description

END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - 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.

Reason for Recall

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

Details

Units Affected
23 units
Distribution
International distribution the country of Japan Only.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled? ▼
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - 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.. Recalled by Synthes (USA) Products LLC. Units affected: 23 units.
Why was this product recalled? ▼
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Low. Recall number: Z-0410-2021.

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