Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677

FDA device recall Z-2218-2008 · posted 2008-09-17 · Terminated

Recall details

Recalling firm

Wright Medical Technology Inc

Reason for recall

Trials are 2.5mm larger than marked.

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

127 units

Distribution

Worldwide Distribution --- including USA and Canada.

Date initiated

2008-05-20

Date posted

2008-09-17

Date terminated

2009-01-25

Location

Arlington, TN