Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Tivanium Self Tapping Screw

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Zimmer Tivanium Self Tapping Screwsee related information
Date Initiated by FirmDecember 12, 2008
Date PostedJanuary 26, 2009
Recall Status1 Terminated 3 on October 30, 2009
Recall NumberZ-0905-2009
Recall Event ID 50694
Product Classification Self Tapping Bone Screw - Product Code HWC
ProductZimmer 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.
Code Information Lots 60548987, 60548986, 60548999, 60557220 and 60557219.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
FDA Determined
Cause 2		Process control
ActionThe 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 in Commerce408
DistributionInternational Distribution including country of Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-