Home / Recalls / Biomet Spine LLC. / Z-0220-2015

Z-0220-2015 Class II Terminated

Recalled by Biomet Spine LLC. — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
November 26, 2014
Initiation Date
March 9, 2011
Termination Date
January 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120

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.

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.

Distribution Pattern

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

Code Information

Lot numbers L532655, L532690, Product code 8503XXXX

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