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

FDA device recall Z-0959-2007 · posted 2007-06-19 · Terminated

Recall details

Recalling firm

Biomet 3i

Reason for recall

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

Action taken

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

Status

Terminated

Product code

DZE

Quantity affected

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.

Date initiated

2007-05-14

Date posted

2007-06-19

Date terminated

2009-09-11

Location

Palm Beach Gardens, FL