Class 2 Device Recall DePuy Spine Bremer Halo System

• Date Initiated by Firm: October 10, 2006
• Date Posted: November 02, 2006
• Recall Status: Terminated on March 27, 2017
• Recall Number: Z-0134-2007
• Recall Event ID: 36504
• 510(K)Number: K915800 K993099
• Product Classification: halo system - Product Code HWC
• Product: Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026
• Code Information: All lot numbers except those beginning with '6' or ending with the letter 'R'
• Recalling Firm/ Manufacturer: DePuy Spine, Inc.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: Matthew King; 508-828-3106
• Manufacturer Reason for Recall: Sterility of device is compromised due to loss of package integrity
• FDA Determined Cause: Other
• Action: DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.
• Quantity in Commerce: 4843 units
• Distribution: Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia
• 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 = HWC; 510(K)s with Product Code = HWC