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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Offset Wire Fixation Bolt used in AceFischer External Fixation System

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  Class 2 Device Recall DePuy Offset Wire Fixation Bolt used in AceFischer External Fixation System see related information
Date Initiated by Firm November 08, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 07, 2013
Recall Number Z-0508-2012
Recall Event ID 60325
510(K)Number K860018  
Product Classification Holder, needle; Orthopedic - Product Code HXK
Product Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.
Code Information Catalog: 8180-50-006, Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy Tinsley
574-372-7136
Manufacturer Reason
for Recall		 DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.
FDA Determined
Cause 2		 Component change control
Action On 11/9/2011 DePuy sent "Medical Device Recall Notice" letters to Distributors and to direct account hospitals. Recall notices included instructions to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN via distributors and sales representatives. The product is going to be discontinued and no reconditioning or reworking for the product is planned. For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - pm EST.)
Quantity in Commerce 890
Distribution Nationwide Distribution
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 = HXK and Original Applicant = BUCKMAN CO., INC.
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