| Class 2 Device Recall Cannulated Hex Screwdriver | |
Date Initiated by Firm | February 19, 2009 |
Date Posted | April 28, 2009 |
Recall Status1 |
Terminated 3 on February 03, 2010 |
Recall Number | Z-1208-2009 |
Recall Event ID |
51431 |
Product Classification |
instrument for use in orthopaedic implant surgery - Product Code LXH
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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 |
Code Information |
Lot numbers: 019598209, 038504328, 058486628, 058507733, 058516752, 067422530, 088538652, 098538652, 107439501, 107442247, 117442247, 0712180, S0701050 |
Recalling Firm/ Manufacturer |
Wright Medical Technology Inc 5677 Airline Rd Arlington TN 38002
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For Additional Information Contact | Debbie Daurer 901-867-4601 |
Manufacturer Reason for Recall | The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated. |
FDA Determined Cause 2 | 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 in Commerce | 682 devices |
Distribution | Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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