Class 2 Device Recall ArthroCare Opus SpeedLock

• Date Initiated by Firm: September 30, 2010
• Date Posted: April 12, 2011
• Recall Status: Terminated on August 01, 2011
• Recall Number: Z-1952-2011
• Recall Event ID: 57830
• 510(K)Number: K090615
• Product Classification: Ligament Fixation Device - Product Code MBI
• Product: ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
• Code Information: Lot Numbers: W100166, WI00167, W100168
• Recalling Firm/ Manufacturer: ArthroCare Corporation ; 680 Vaqueros Ave; Sunnyvale CA 94085-3523
• For Additional Information Contact: Bruce Prothro ; 408-736-0224 Ext. 229
• Manufacturer Reason for Recall: During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
• FDA Determined Cause: Process control
• Action: On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.
• Quantity in Commerce: 170 units
• Distribution: Product was released for distribution in US.
• 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.

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