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U.S. Department of Health and Human Services

Class 2 Device Recall Sirus

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  Class 2 Device Recall Sirus see related information
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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Connie Morgan
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
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

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.