Recalls / —
—#76131
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.
- FDA product code
- HWC — Screw, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lots 60548987, 60548986, 60548999, 60557220 and 60557219.
Why it was recalled
The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Zimmer Inc.
- Address
- 345 E Main St, Warsaw, Indiana 46580-2746
Distribution
- Distribution pattern
- International Distribution including country of Japan.
Timeline
- Recall initiated
- 2008-12-12
- Posted by FDA
- 2009-01-26
- Terminated
- 2009-10-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #76131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.