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U.S. Department of Health and Human Services

Class 2 Device Recall Dynasty Trial Shell

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  Class 2 Device Recall Dynasty Trial Shell see related information
Date Initiated by Firm May 20, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on January 25, 2009
Recall Number Z-2218-2008
Recall Event ID 48687
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002

Orthopaedic instrument used for the preparation of the implant site prior to device implantation.
Code Information Lot Nos.: 037386983 and 117459853
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall		 Trials are 2.5mm larger than marked.
FDA Determined
Cause 2		 Component change control
Action The firm initiated their recall on May 20, 2008 by issuing a Field Notice to their distributors and followed with telephone calls on May 21 and 22, 2008 requesting the return of the products. The firm then issued letters to their distributors on June 4, 2008 explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals were notified of the recall also on June 4, 2008 by means of letters, delivered via Fed Ex, addressed to Hospital Administrators, Risk Managers, and Orthopaedic Department Managers.
Quantity in Commerce 127 units
Distribution Worldwide Distribution --- including USA and Canada.
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.
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