Class 3 Device Recall BacFix

• Date Initiated by Firm: April 01, 2002
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 11, 2004
• Recall Number: Z-0920-04
• Recall Event ID: 28488
• 510(K)Number: K964404
• Product Classification: Appliance, Fixation, Spinal Interlaminal - Product Code KWP
• Product: 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas
• Code Information: All codes
• Recalling Firm/ Manufacturer: 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: Other
• 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: 145
• 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