Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile,
FDA device recall Z-1208-2009 · posted 2009-04-28 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 682 devices
- Distribution
- Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.
- Date initiated
- 2009-02-19
- Date posted
- 2009-04-28
- Date terminated
- 2010-02-03
- Location
- Arlington, TN
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