Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, 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.
FDA Recall Z-2217-2008 · Posted 2008-09-17
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-05-20
Date Terminated2009-01-25
Product Quantity127 units
Reason for Recall
Trials are 2.5mm larger than marked.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution --- including USA and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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