Recall Z-0220-2015 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Biomet Spine LLC.
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
| Date | Dec 16, 2014 (initiated Mar 9, 2011) |
| Status | Terminated |
| Reason | Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. |
| Root cause | Device Design |
| Action | Biomet notified customers by phone on March 9, 2011 to return the affected product. |
| Quantity | 120 |
| Distribution | US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102738 | LANX FUSION SYSTEM Lanx, LLC, Feb 10, 2011 |