Recall Z-2258-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spine Smith Holdings, LLC
VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
| Date | Sep 19, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | The product has the potential to be laser marked as a Medium when it actually is a Small. |
| Root cause | Process control |
| Action | The firm decided to remove this lot and verify all of the markings. A stock sweep for mis-marked parts was performed at the time and it is not known why this lot is identified, however an additional stock sweep of all PEEK products from all product lines was performed beginning 07/31/2013 and no additional lots were identified. |
| Quantity | 32 |
| Distribution | Distributed in FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM Spine Smith Partners L.P., Sep 30, 2010 |