| Class 2 Device Recall Dynasty Trial Shell | |
Date Initiated by Firm | May 20, 2008 |
Date Posted | September 17, 2008 |
Recall Status1 |
Terminated 3 on January 25, 2009 |
Recall Number | Z-2217-2008 |
Recall Event ID |
48687 |
Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
|
Product | 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. |
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.
|
|
|
|