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Terminated

Biomet 3 i, Disposable Twist Drills, Model Number DT2715.

FDA Recall Z-0959-2007 · Posted 2007-06-19

Recalling FirmBiomet 3i
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-05-14
Date Terminated2009-09-11
Product Quantity147

Reason for Recall

The depth indicator laser line markings on the drills are too faint for clinicians to read during use.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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