FDAClass IIINovember 11, 2020

Standard Ring 17mm X 22mm recall

STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar…

Why was Standard Ring 17mm X 22mm recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 25P6483 3L27511

Product
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar…
Recalling firm
Synthes (USA) Products LLC
Quantity
7 units
Distribution
International distribution the country of Japan Only.
Recall date
November 11, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
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