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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Tivanium Self Tapping Screw

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  Class 2 Device Recall Zimmer Tivanium Self Tapping Screw see related information
Date Initiated by Firm December 12, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on October 30, 2009
Recall Number Z-0904-2009
Recall Event ID 50694
Product Classification Self Tapping Bone Screw - Product Code HWC
Product Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904000. NOTE: This product is not sold in the United States.

The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile.
Code Information Lot 60557215.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
FDA Determined
Cause 2		 Process control
Action The firm's facility in Japan was notified via letter, "Urgent: Device Recall" (dated 12/11/08) and requested to complete an enclosed Inventory Return Certification form. The letter instructed distributors to notify accounts to the user level to stop using the affected implants and return them to the Zimmer Distribution Center in the U.S. and fax (574-372-4265) a copy of the completed Inventory Return Certification form to Zimmer, Inc. For questions about the recall, please contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 100
Distribution International Distribution including country of Japan.
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.
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