—#80263

Product

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 product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot numbers: 019598209, 038504328, 058486628, 058507733, 058516752, 067422530, 088538652, 098538652, 107439501, 107442247, 117442247, 0712180, S0701050

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2009-02-19
Posted by FDA: 2009-04-28
Terminated: 2010-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80263. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.