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Class 2 Device Recall |
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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
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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/ Manufacturer |
Warsaw Orthopedic, Inc. 2500 Silveus Xing Warsaw IN 46582-8598
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For Additional Information Contact |
800-933-2635
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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