Class 2 Device Recall Disposable Twist Drills

• Date Initiated by Firm: May 14, 2007
• Date Posted: June 19, 2007
• Recall Status: Terminated on September 11, 2009
• Recall Number: Z-0959-2007
• Recall Event ID: 37994
• Product Classification: Drills - Product Code DZE
• Product: Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
• Code Information: Lot Numbers: 635699 and 652460
• Recalling Firm/ Manufacturer: Biomet 3i; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: 561-776-6700 Ext. 6819
• Manufacturer Reason for Recall: The depth indicator laser line markings on the drills are too faint for clinicians to read during use.
• FDA Determined Cause: Other
• Action: Each domestic consignee was contacted on 5/14/07 by phone using a prepared script. A follow up letter was then faxed to each consignee. International consignees were contacted by email followed by a faxed letter. Each consignee was instructed to examine their inventory for the recalled product. They were requested to complete and fax back a response form to Biomet and to return any affected product.
• Quantity in Commerce: 147
• Distribution: World Wide: USA states including: NY, MA, MD, NJ, IL, DE, RI, CA, MI, VA, KS and fL. Internationally to Brazil, Germany, France, Great Briton Japan, Greece and Italy.
• Total Product Life Cycle: TPLC 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.