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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MAX
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