Class 2 Device Recall ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE

• Date Initiated by Firm: August 30, 2012
• Date Posted: October 10, 2012
• Recall Status: Terminated on August 15, 2013
• Recall Number: Z-0037-2013
• Recall Event ID: 63157
• 510(K)Number: K021461 K063100 K081038
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• Product: ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
• Code Information: All lots except those starting with SY
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Place; Memphis TN 38132
• For Additional Information Contact: Rita Tate; 901-396-3010
• Manufacturer Reason for Recall: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Medtronic conducted a conference call on August 30, 2012 and sent an "URGENT VOLUNTARY RECALL" notice dated September 3, 2012 to all affected customers. The notice identified the product, problem, and actions to be taken by the customers. A Recall Questionnaire Form was attached to the letter for customers to complete and return. Contact your Medtronic Sales representative or the firm's Global Quality Department at 800-876-3133, ext. 3197 for questions regarding this notice.
• Quantity in Commerce: 1014 units
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
• 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 = KWQ; 510(K)s with Product Code = KWQ