Recall Z-0904-2009 ยท HWC Screw, Fixation, Bone
Zimmer Inc.
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.
| Date | Jan 26, 2009 (initiated Dec 12, 2008) |
| Status | Terminated |
| Reason | The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa. |
| Root cause | 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 | 100 |
| Distribution | International Distribution including country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.