Class 2 Device Recall OPUS SpeedStitch Suture Cartridge

• Date Initiated by Firm: June 28, 2006
• Date Posted: August 02, 2006
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-1312-06
• Recall Event ID: 35878
• 510(K)Number: K022229
• Product Classification: endoscopic suturing device - Product Code KOG
• Product: OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures.
• Code Information: All products consisting of lot number 110399, Catalog number OM-6006. This catalog number is referred to as the OPUS MiniPlus Implant Set.
• Recalling Firm/ Manufacturer: ArthroCare Corporation; 680 Vaqueros Ave; Sunnyvale CA 94085-3523
• Manufacturer Reason for Recall: The product may lose sterility due to omission of the final pouch seal.
• FDA Determined Cause: Packaging process control
• Action: The firm has issued notification letters to all customers in the United States on June 29, 2006 via overnight delivery, advising customers to return all product with incomplete or missing seals to Arthocare.
• Quantity in Commerce: 198 units
• Distribution: Nationwide.

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.

• 510(K) Database: 510(K)s with Product Code = KOG