Recall Z-1698-2012 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Genesys Orthopedic Systems, LLC
Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.
| Date | Jun 1, 2012 (initiated Aug 24, 2011) |
| Status | Terminated |
| Reason | The inserters have the potential to break. |
| Root cause | Reprocessing Controls |
| Action | Genesys Orthopedic Systems, LLC decided to recall the affected product and called their customers on August 24, 2011. The firm removed the inserters from distribution from 8/24-31/2011. |
| Quantity | 4 inserters |
| Distribution | Nationwide Distribution including Florida and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103034 | GENESYS SPINE INTERBODY FUSION SYSTEM Genesys Spine, Dec 10, 2010 |