3.0mm Locking Screw LOW Profile recall
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
Why was 3.0mm Locking Screw LOW Profile 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: 13L2504 M22
- Product
- 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 18 units
- Distribution
- International distribution the country of Japan Only.
- Recall date
- November 11, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)