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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 04, 2005
Date Posted January 28, 2005
Recall Status1 Terminated 3 on June 30, 2005
Recall Number Z-0451-05
Recall Event ID 30854
Product Classification Screw, Fixation, Bone - Product Code HWC
Product ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145.
Code Information Lots 634590, 671730, 789870, 789860, 796020, 789880 and 744910.
Recalling Firm/
Warsaw Orthopedic, Inc.
2500 Silveus Xing
Warsaw IN 46582-8598
For Additional Information Contact
Manufacturer Reason
for Recall
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
FDA Determined
Cause 2
Action Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.
Quantity in Commerce 182
Distribution Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
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.