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U.S. Department of Health and Human Services

Class 2 Device Recall ILLICO access retractor

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  Class 2 Device Recall ILLICO access retractor see related information
Date Initiated by Firm January 28, 2009
Date Posted December 11, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-0498-2010
Recall Event ID 51734
Product Classification Retractor - Product Code GAD
Product ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520

The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site.
Code Information Lot number: 5271901
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
2051 Palomar Airport Rd Ste 100
Carlsbad CA 92011-1462
For Additional Information Contact
760-431-9286
Manufacturer Reason
for Recall		 The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.
FDA Determined
Cause 2		 Device Design
Action On January 28, 2009 Alphatec Spine contacted their domestic consignees via telephone and the international consignee was contacted via telephone and electronic mail. Alphatec Spine's telephone call consisted of informing the consignees of the product affected, the problem, what actions needed to be taken and what action Alphatec Spine would take to arrange for pick-up of the affected products.
Quantity in Commerce 14
Distribution AZ, CA, OR, TX, and Tokyo, Japan.
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.
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