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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 Recall
DYNASTY(R) BIOFOAM(R) SHELL
see related information
Date Posted February 14, 2012
Recall Status1 Terminated on March 13, 2013
Recall Number Z-1031-2012
Recall Event ID 60947
Premarket Notification
510(K) Number
K082924 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
Product DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, 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: 119925745, 129941906, 129964152, 0401027024, 0401047124, 0401055980, 0401065584, 04096415201
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002-9501
For Additional Information Contact Cathy A.M. Park
901-867-4324
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
PRODUCTION CONTROLS: Packaging
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 13 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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