| | Class 2 Device Recall Sirus |  |
| Date Initiated by Firm | September 30, 2005 |
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| Date Posted | October 28, 2005 |
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| Recall Status1 |
Terminated 3 on December 28, 2005 |
| Recall Number | Z-0091-06 |
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| Recall Event ID |
33810 |
| Product Classification |
Bit, Surgical - Product Code GFG
|
| Product | Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039. |
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| Code Information |
Lots 480103, 480104 and 487665. |
| FEI Number |
1000220733
|
Recalling Firm/
Manufacturer |
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
|
| For Additional Information Contact | Connie Morgan
574-372-4269 |
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Manufacturer Reason
for Recall | The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified via recall letter dated 9/30/05. |
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| Quantity in Commerce | 27 |
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| Distribution | Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia. |
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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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