Zimmer TIV Self Tap Screw, 42 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904200. 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.
Recall
- Recall Number
- Z-0905-2009
- Event Number
- 50694
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 12, 2008
- Posted
- January 26, 2009
- Terminated
- October 30, 2009
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
Zimmer TIV Self Tap Screw, 42 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904200. 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.
The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
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.
International Distribution including country of Japan.
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