SpineNet Anterior Cervical Cage recall
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in…
Why was SpineNet Anterior Cervical Cage recalled?
The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
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?
Ref. No. CL1012-05 Size 10mm x 12mm x 5mm, Ref. No. CL1012-06 Size 10mm x 12mm x 6mm, Ref. No. CL1012-07 Size 10mm x 12mm x 7mm, Ref. No. CL1012-08 Size 10mm x 12mm x 8mm, Ref. No. CL1012-09 Size 10mm x 12mm x 9mm, Ref. No. CL1012-10 Size 10mm x 12mm x 10mm, Ref. No. CL1014-05 Size 12mm x 14mm x 5mm, Ref. No. CL1014-06 Size 12mm x 14mm x 6mm, Ref. No. CL1014-07 Size 12mm x 14mm x 7mm, Ref. No. CL1014-08 Size 12mm x 14mm x 8mm, Ref. No. CL1014-09 Size 12mm x 14mm x 9mm, and Ref. No. CL1014-10 Size 12mm x 14mm x 10mm.
- Product
- SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in…
- Recalling firm
- SpineNet
- Quantity
- 400
- Distribution
- USA Nationwide Distribution in the state of Florida
- Recall date
- September 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)