—#71869

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Nos.: 037386983 and 117459853

Why it was recalled

Trials are 2.5mm larger than marked.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002-9501

Distribution

Distribution pattern: Worldwide Distribution --- including USA and Canada.

Timeline

Recall initiated: 2008-05-20
Posted by FDA: 2008-09-17
Terminated: 2009-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71869. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.