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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lot 60557215.
Products Sold
Lot 60557215.
Zimmer Inc. is recalling Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer due to The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026