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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Spine.Bremer Halo System

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  Class 2 Device Recall DePuy Spine.Bremer Halo System see related information
Date Initiated by Firm October 10, 2006
Date Posted November 02, 2006
Recall Status1 Terminated 3 on March 27, 2017
Recall Number Z-0132-2007
Recall Event ID 36504
510(K)Number K915800  K993099  
Product Classification halo system - Product Code HWC
Product 12 Degree Slider Set, DePuy Spine Bremer Halo System
Product Code: 2923-01-020
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 2		 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 66 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 and Original Applicant = BREMER MEDICAL, INC.
510(K)s with Product Code = HWC and Original Applicant = DEPUY ACROMED
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