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.
FDA Recall Z-0220-2015 · Posted 2014-12-16
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Recalling FirmBiomet Spine LLC.
Recall StatusTerminated
Product CodeMAX
Date Initiated2011-03-09
Date Terminated2015-01-07
Product Quantity120
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.
Firm Action
Biomet notified customers by phone on March 9, 2011 to return the affected product.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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