FDA-Device2014-11-26Class II
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.
Biomet Spine LLC.
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.
Sold states
US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Affected count
120
Manufactured in
310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0220-2015Don't want to check this manually?
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