Class 2 Device Recall Sequoia final driver closure top retention

• Date Initiated by Firm: April 04, 2011
• Date Posted: June 29, 2011
• Recall Status: Terminated on August 28, 2013
• Recall Number: Z-2705-2011
• Recall Event ID: 58376
• 510(K)Number: K072672
• Product Classification: Instrument, surgical, non-powered - Product Code HAO
• Product: Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, Texas, The device is used to apply final torque to closure tops of the implant.; ; The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal.
• Code Information: 60LJ, 60LK, 60LL, 61HZ, 61RS, 64DC, 64DC.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Christopher Harrold; 574-267-6131
• Manufacturer Reason for Recall: A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.
• FDA Determined Cause: Device Design
• Action: The firm, ZIMMER, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 4, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that each instrument tray had both final drivers (with and without retention feature); contact their customer service representative if they do not have both versions; ensure proper seating of the drive by moving the driver side to side, and complete and return the Distributor Certification Form via fax to: Zimmer Spine at 512-258-0995. The letter states the firm will be distributing the version of the screwdriver with no retention feature beginning in March 2011 and distributing the new surgical technique in April 2011. The firm is including an additional final driver in the instrument tray for final tightening of the closure tops. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.
• Quantity in Commerce: 505 devices
• Distribution: Worldwide distribution: USA (nationwide) including the states of: AL, AZ, CA, CT, CO, FL, GA, LA, MI, MN, MO, NC, NY, OH, OK, PA, TN, TX, WA and WI; and countries of: Czech Republic, Denmark, France, Singapore, Spain, Switzerland, and United Kingdom.
• 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 = HAO and Original Applicant = ABBOTT SPINE, INC.