Class 2 Device Recall Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set

• Date Initiated by Firm: October 02, 2010
• Date Posted: December 27, 2010
• Recall Status: Terminated on April 15, 2011
• Recall Number: Z-0818-2011
• Recall Event ID: 56894
• Product Classification: Tray, Surgical - Product Code LRP
• Product: Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
• Code Information: Not lot coded
• Recalling Firm/ Manufacturer: DePuy Spine, Inc.; 325 Paramount Drive; Raynham MA 02767
• For Additional Information Contact: SAME; 508-828-3769
• Manufacturer Reason for Recall: The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
• FDA Determined Cause: Labeling design
• Action: Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.
• Quantity in Commerce: 121 units
• Distribution: Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.
• 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.