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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Spine Cyclone anterior cervical plate system

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  Class 2 Device Recall Zimmer Spine Cyclone anterior cervical plate system see related information
Date Initiated by Firm March 26, 2008
Date Posted September 01, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1744-2008
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, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-172.
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 2
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.
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