Class 2 Device Recall BD Beaver ArthroLok Pointed Tip 4mm Blade

• Date Initiated by Firm: June 12, 2009
• Date Posted: May 21, 2010
• Recall Status: Terminated on January 26, 2012
• Recall Number: Z-1638-2010
• Recall Event ID: 52291
• Product Classification: Knife, orthopedic - Product Code HTS
• Product: BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.
• Code Information: Lot Number: 7291713, Expiration Date: 2012-10.
• Recalling Firm/ Manufacturer: Becton Dickinson and Company; 411 Waverley Oaks Rd Ste 2229; Waltham MA 02452-8448
• For Additional Information Contact: SAME; 781-906-7950
• Manufacturer Reason for Recall: Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.
• FDA Determined Cause: Packaging process control
• Action: Becton Dickinson issued an "Urgent: Field Safety Notice" beginning June 25, 2009 by telephone and letter fax to remove and discard affected product from their possession. Customer verification responses were requested. For further information, contact Becton Dickinson and Company at 1-781-906-7900.
• Quantity in Commerce: 354 units
• Distribution: Worldwide Distribution -- United States, Japan and Belgium.
• 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.