Wright Medical Technology Inc Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.

Recommended Action

Per FDA guidance

Wright Medical notified their distributors of the recall on 03/11/2009 by letter 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 and surgeons were notified of the recall also on 03/11/2009. All letters were delivered by Fed Ex.