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Biomet Spine LLC. recalls LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implan
Recalled November 26, 2014 · FDA recall Z-0220-2015 · Biomet Spine
Hazard
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. · FDA Class II
Units
120
Sold at
US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Description
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
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.
Manufacturer(s)
Biomet Spine LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →