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
This recall has been terminated (originally issued April 28, 2009).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- February 19, 2009
- Posted
- April 28, 2009
- Terminated
- February 3, 2010
- Recall Number
- Z-1208-2009
- Quantity
- 682 devices
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.
Distribution
Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.
Lot / Code Info
Lot numbers: 019598209, 038504328, 058486628, 058507733, 058516752, 067422530, 088538652, 098538652, 107439501, 107442247, 117442247, 0712180, S0701050
Root Cause
Process design
Action Taken
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.