END Ring 17mm X 22mm Lateral or Anterior/0 DEG recall
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical…
Why was END Ring 17mm X 22mm Lateral or Anterior/0 DEG 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: 43P3070 45P9029 48P09506 H873508
- Product
- END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 9 units
- Distribution
- International distribution the country of Japan Only.
- Recall date
- November 11, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)