Reported Sep 4, 2013 · Terminated
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage:…
SpineNet
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SpineNet · 1300 Minnesota Ave · Winter Park, FL · 32789-4800
Is this the product you have?
- SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona
- Anterior Cervical Cage) Product UsageIs indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
- Lot codes and dates
- 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.
- Amount recalled
- 400
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- FL
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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