Z-2103-2013 Class II Terminated
FDA device recall Z-2103-2013 was initiated by SpineNet on February 5, 2013 and is designated Class II. Reason for recall: 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 mark… The recall status is terminated (terminated May 2, 2014). Affected quantity: 400.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- February 5, 2013
- Termination Date
- May 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400
Product Description
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
Reason for Recall
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.
Distribution Pattern
USA Nationwide Distribution in the state of Florida
Code Information
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.