| Class 2 Device Recall DYNASTY(R) BIOFOAM(R) SHELL | |
Date Initiated by Firm | January 03, 2012 |
Date Posted | February 14, 2012 |
Recall Status1 |
Terminated 3 on March 13, 2013 |
Recall Number | Z-1031-2012 |
Recall Event ID |
60947 |
510(K)Number | K082924 |
Product Classification |
Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
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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 TN 38002-9501
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWA
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