Class 2 Device Recall Spinous Process Clamp

• Date Initiated by Firm: June 29, 2017
• Create Date: September 21, 2017
• Recall Status: Terminated on July 24, 2023
• Recall Number: Z-3143-2017
• Recall Event ID: 77894
• 510(K)Number: K131425
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall; When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.
• Code Information: P/N 9734715, 9734716
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 826 Coal Creek Cir; Louisville CO 80027-9710
• For Additional Information Contact: Medtronic Technical Services; 800-595-9709
• Manufacturer Reason for Recall: Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
• FDA Determined Cause: Device Design
• Action: Medtronic sent an Urgent Medical Device Correction letter dated June 27, 2017, to all affected consignees. The letter notifies consignees of the product correction and requests that practitioners follow the attached use instructions for devices. Practitioners are to identify product damage before each procedure by opening and closing the device jaw with the T-handle. It is instructed that practitioners not continue turning the screw if resistance is met, as this may break the washer. Clamps are not to be used if the jaws remain closed when attempting to open a clamp or if the clamp screw back is out of the clamp. It is asked that this check is done to all inventory and any damaged product is to be reported to Medtronic at 1-800-595-9709 and quarantined. Revised product is available. Consignees are asked to complete and return the provided Consignee Response Form by email to the firm at RS.NavFCA@medtronic.com or by fax to 651-367-7075. Any questions can be directed to 1-800-595-9709.
• Quantity in Commerce: 2,051 units total
• Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania, Australia, Bangladesh, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Kenya, Latvia, Luxembourg, Malaysia, Martinique, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, & Vietnam.
• 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 = OLO and Original Applicant = MEDTRONIC NAVIGATION, INC.