Biomet Spine LLC.: Medical Device Recall in 2014 - (Recall #: Z-0220-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: March 9, 2011
Date Posted: November 26, 2014
Recall Number: Z-0220-2015
Event ID: 69615
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.

Status: Terminated
Product Quantity: 120
Code Information:

Lot numbers L532655, L532690, Product code 8503XXXX

Distribution Pattern:

US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,

Voluntary or Mandated:

Voluntary: Firm initiated