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Terminated

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

FDA Recall Z-1208-2009 · Posted 2009-04-28

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2009-02-19
Date Terminated2010-02-03
Product Quantity682 devices

Reason for Recall

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

Firm Action

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.

Root Cause

Process design

Distribution Pattern

Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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