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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Twist Drills

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  Class 2 Device Recall Disposable Twist Drills see related information
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
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 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

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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