Recall Z-1208-2009 ยท LXH Orthopedic Manual Surgical Instrument
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
| Date | Apr 28, 2009 (initiated Feb 19, 2009) |
| Status | Terminated |
| Reason | The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated. |
| Root cause | Process design |
| 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. |
| Quantity | 682 devices |
| Distribution | Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.