Device product
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.
Z-0220-2015
Product summary
- Event
- Event 69615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120
- Official record key
device-enforcement:Z-0220-2015
Official wording
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.
Code information: Lot numbers L532655, L532690, Product code 8503XXXX
Distribution pattern: US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Derived failure modes
-
Unknown
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.