Class 2 Device Recall DUFNER Instrumente GmbH

• Date Initiated by Firm: June 03, 2020
• Create Date: July 10, 2020
• Recall Status: Terminated on January 21, 2021
• Recall Number: Z-2534-2020
• Recall Event ID: 85894
• Product Classification: Holder, needle, gastroenterologic - Product Code FHQ
• Product: DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
• Code Information: Lot Numbers: 8170368 and 8180673
• FEI Number: 3002806862
• Recalling Firm/ Manufacturer: Dufner Instrumente GmbH; Fohrenstr. 9; Tuttlingen Germany
• Manufacturer Reason for Recall: Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
• FDA Determined Cause: Process control
• Action: Dufner Instruments GMB issued letter dated June 3, 2020, staing reason for recall, health risk and action to take: 1. Immediately remove all products of the affected article number with the named lots fromyour warehouse or from affected instrument trays to prevent further use. 2. With this letter you will receive a confirmation form, please fill it in completely, sign it and send it back to us after receiving this information. If you do not own any affected products, please fill out the confirmation form anyway and fax it to +49 (0)7461/79419 or mail it to d.moehrle@dufner-tuttlingen.de. 3. Send back to us immediately all products still in stock. After receipt of the goods we will send you a credit note and clarify with you the further procedure. 4. Pass this information on to all staff in your institution, who should be informed. Please ensure that all users of the affected products within your organization and also all other affected persons receive this information through the Field Safety Notice. If products have been passed on to third parties, please also send them a copy of the Field Safety Notice or inform our contact person to contact the third parties,
• Quantity in Commerce: 30 units
• Distribution: IL
• Total Product Life Cycle: TPLC Device Report

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.