Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0959-2007

Biomet 3 i, Disposable Twist Drills, Model Number DT2715

ZimVie US Corp LLC / initiated 2007-05-14 / Terminated

Biomet 3i began a recall of Biomet 3 i, Disposable Twist Drills, Model Number DT2715 on . The reason FDA records is "The depth indicator laser line markings on the drills are too faint for clinicians to read during use". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0959-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ZimVie US Corp LLC
Product
Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
Product code
DZE Implant, Endosseous, Root-Form
Reason for recall
The depth indicator laser line markings on the drills are too faint for clinicians to read during use.
FDA root 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.
Product codes and lots
Lot Numbers: 635699 and 652460