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.

Name: 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.
Brand: Biomet Spine Llc.

This recall has been terminated (originally issued December 16, 2014).

Company: Biomet Spine Llc.
Recall Initiated: March 9, 2011
Posted: December 16, 2014
Terminated: January 7, 2015
Recall Number: Z-0220-2015
Quantity: 120
Firm Location: Broomfield, CO
Official Source: View on FDA website ↗

Reason for Recall

Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.