Class 2 Device Recall DePuy Spine

• Date Initiated by Firm: March 22, 2011
• Date Posted: April 27, 2011
• Recall Status: Terminated on February 20, 2013
• Recall Number: Z-2102-2011
• Recall Event ID: 58271
• Product Classification: Spinal channeling instrument, vertebroplasty - Product Code OCJ
• Product: Confidence¿ Diamond Tip Introducer Needle 11G x 6-Inch; Product Code: 2839-03-611; ; The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.
• Code Information: Lot Code: HLPB4G
• Recalling Firm/ Manufacturer: DePuy Spine, Inc.; 325 Paramount Drive; Raynham MA 02767
• For Additional Information Contact: 508-828-3769
• Manufacturer Reason for Recall: Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
• FDA Determined Cause: Packaging process control
• Action: The firm, DePuy Spine, sent an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated March 22, 2011 to its consignees/customers ( hospital sites and domestic sales distributors). A product reconciliation form was provided to assist in the retrieval of affected product. The letter described the product, problem and actions to be taken. The customers were instructed to return any needles that they may have to their local Distributor for DePuy Spine products and complete and return the Product Reconciliation Form via fax to 508-828-3762; call Customer Service at 877-379-4871 to receive a return goods authorization number and/or mail the form with the return product to DePuy Spine Inc., 50 Scotland Boulevard, Bridgewater, MA 02324, Attn: CONFIDENCE NEEDLE RECALL COORDINATOR, RGA #. If you have any questions or concerns with regard to this notice, please contact the DePuy Spine Regulatory Compliance Department at 508-828-2790.
• Quantity in Commerce: 215 units
• Distribution: Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.
• 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.