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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Spine Durango Anchored ALIF Plate

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  Class 2 Device Recall Biomet Spine Durango Anchored ALIF Plate see related information
Date Initiated by Firm March 09, 2011
Date Posted December 16, 2014
Recall Status1 Terminated 3 on January 07, 2015
Recall Number Z-0220-2015
Recall Event ID 69615
510(K)Number K102738  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
Code Information Lot numbers L532655, L532690, Product code 8503XXXX
Recalling Firm/
Manufacturer		 Biomet Spine LLC.
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Mr. Mike Medina
303-443-7500 Ext. 244
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Biomet notified customers by phone on March 9, 2011 to return the affected product.
Quantity in Commerce 120
Distribution US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = LANX, LLC
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