Class 2 Device Recall CapsLock Cannula

• Date Initiated by Firm: July 12, 2005
• Date Posted: July 22, 2005
• Recall Status: Terminated on July 24, 2006
• Recall Number: Z-1043-05
• Recall Event ID: 32688
• Product Classification: Cannula, Surgical, General & Plastic Surgery - Product Code GEA
• Product: ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.
• Code Information: Lot Numbers: 1905, 1904
• Recalling Firm/ Manufacturer: ArthroCare Corporation; 680 Vaqueros Ave; Sunnyvale CA 94085-3523
• Manufacturer Reason for Recall: Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection
• FDA Determined Cause: Other
• Action: The firm (Arthocare UK) has issued notification letters to all consignees via overnight delivery informing them of the situation.
• Quantity in Commerce: 500 units, 180 in the U.S., 320 aborad
• Distribution: The product was distributed to 19 consignees in foreign countries, including Denmark, Spain, Lebanon, Finland, Saudi Arabia, the UK, Egypt, Italy, and Australia, as well as 12 medical facilities in New Jersey, New York, Ohio, Maryland, Montana, Oregon, Illinois, Washington, Wisconsin and Nevada. Dates of distribution and manufacture are approximations, provided by the recalling firm.
• 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.