| Class 2 Device Recall Disposable Twist Drills |  |
Date Initiated by Firm | May 14, 2007 |
Date Posted | June 19, 2007 |
Recall Status1 |
Terminated 3 on September 11, 2009 |
Recall Number | Z-0959-2007 |
Recall Event ID |
37994 |
Product Classification |
Drills - Product Code DZE
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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
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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 2 | 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 |
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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.
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