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