FDA Medical Device Recalls (openFDA)
Zimmer Inc.: 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 number
- Z-0905-2009
- Recalling firm
- Zimmer Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-12-12
- Posted
- 2009-01-26
- Terminated
- 2009-10-30
- 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
- 408
- Distribution
- International Distribution including country of Japan.
- Lot, serial or model codes
- Lots 60548987, 60548986, 60548999, 60557220 and 60557219.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28