Date Initiated by Firm |
August 16, 2007 |
Date Posted |
December 31, 2008 |
Recall Status1 |
Terminated 3 on January 12, 2009 |
Recall Number |
Z-0507-2009 |
Recall Event ID |
48177 |
Product Classification |
Spinal Vertebral Body Replacement Device - Product Code MQP
|
Product |
Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120.
Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems. |
Code Information |
Lot Number: 611884 |
Recalling Firm/ Manufacturer |
Alphatec Spine, Inc. 2051 Palomar Airport Rd Ste 100 Carlsbad CA 92011-1462
|
For Additional Information Contact |
Paula Morgan 760-431-9286 Ext. 6769
|
Manufacturer Reason for Recall |
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
|
FDA Determined Cause 2 |
Process control |
Action |
The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back. |
Quantity in Commerce |
3 units |
Distribution |
Nationwide Distribution --- including states of AZ, FL, NY & TX. |
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.
|