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Recall Observatory FDA recall evidence

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

March 09, 2011

Class II

Product summary

Firm
Biomet Spine LLC.
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

    reason.no_named_rule · v1.0.0

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