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U.S. Department of Health and Human Services

Class 3 Device Recall BacFix

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  Class 3 Device Recall BacFix see related information
Date Initiated by Firm April 01, 2002
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 11, 2004
Recall Number Z-0921-04
Recall Event ID 28488
510(K)Number K983260  
Product Classification Appliance, Fixation, Spinal Interlaminal - Product Code KWP
Product 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas
Code Information All Codes
Recalling Firm/
Spinal Concepts, Inc
5301 Riata Park Ct Bldg F
Austin TX 78727-3436
Manufacturer Reason
for Recall
The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
FDA Determined
Cause 2
Action The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
Quantity in Commerce 183
Distribution Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy
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 = KWP and Original Applicant = SPINAL CONCEPTS, INC.