| | Class 2 Device Recall |  |
| Date Initiated by Firm | January 04, 2005 |
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| Date Posted | January 28, 2005 |
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| Recall Status1 |
Terminated 3 on June 30, 2005 |
| Recall Number | Z-0450-05 |
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| 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 786-142. |
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| Code Information |
Lots 634580, 796070, 857390, 796030, 802090 and 878300. |
Recalling Firm/
Manufacturer |
Warsaw Orthopedic, Inc.
2500 Silveus Xing
Warsaw IN 46582-8598
|
| For Additional Information Contact |
800-933-2635 |
|---|
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 |
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| 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. |
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| Quantity in Commerce | 214 |
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| Distribution | Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia. |
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| 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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