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
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