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U.S. Department of Health and Human Services

Class 2 Device Recall DYNASTY(R) BIOFOAM(R) SHELL

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  Class 2 Device Recall DYNASTY(R) BIOFOAM(R) SHELL see related information
Date Initiated by Firm January 03, 2012
Date Posted February 14, 2012
Recall Status1 Terminated 3 on March 13, 2013
Recall Number Z-1016-2012
Recall Event ID 60947
510(K)Number K082924  
Product Classification Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
Product DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component.

The instrument is used as a hip acetabular shell.
Code Information Lot Numbers: 069846528, 119925740, 010970893, 020998825, 079853470, 79859628, 079868615, 089870267, 089875761, 089878278, 099890880, 099907005, 109917381, 109921935, 119925740, 119930199, 129937584, 0201014640, 0311295429, 0401072697, 0501102202, 0611368642, 0711367603, 0711367604, 0801144244, 0801150043, 0901165305, 04189088001, 04193758401, 04198097901, 05983919310, 05984293410, 06984652810
Recalling Firm/
Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Cathy A.M. Park
Manufacturer Reason
for Recall
The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
FDA Determined
Cause 2
Action Wright Medical sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. A Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact Customer Service at 1-800-238-7117 for questions regarding this recall.
Quantity in Commerce 160 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, 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 = KWA and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.