Class 2 Device Recall Zimmer Spine Cyclone anterior cervical plate system

• Date Initiated by Firm: March 26, 2008
• Date Posted: September 01, 2008
• Recall Status: Terminated on November 12, 2009
• Recall Number: Z-1719-2008
• Recall Event ID: 47527
• 510(K)Number: K031214 K040397
• Product Classification: Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
• Product: Zimmer Spine Cyclone anterior cervical plate, 1 Level, 18MM (Ti-6Al-4V); REF 600-01-118.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-777-7505
• Manufacturer Reason for Recall: The screw locking cap may fracture when the surgeon rotates it into the locked position.
• FDA Determined Cause: Device Design
• Action: Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance.
• Distribution: Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.
• 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 and Original Applicant = ENCORE MEDICAL, L.P.