Recall Z-0932-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spine Smith Partners LP
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
| Date | Mar 10, 2013 (initiated Aug 24, 2012) |
| Status | Terminated |
| Reason | Implants were incorrectly laser marked as 23mm instead of 28mm. |
| Root cause | Labeling mix-ups |
| Action | Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice. |
| Quantity | 3 units |
| Distribution | Distributed in Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM Spine Smith Partners L.P., Jul 1, 2010 |