Recall Z-0220-2015— Biomet Spine LLC.

Name: FDA recall Z-0220-2015
Creator: U.S. Food and Drug Administration
Published: 2011-03-09

Class II · Terminated

Class II FDA medical device recall by Biomet Spine LLC., initiated 2011-03-09, terminated 2015-01-07. It names one FDA 510(k) clearance: K102738. 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.. 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..

Recalling firm: Biomet Spine LLC.
Classification: Class II
Status: Terminated
Initiated: 2011-03-09
Terminated: 2015-01-07
Firm location: Broomfield, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K102738 — LANX FUSION SYSTEMLanx, LLC·cleared 2011-02-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.