FDA Medical Device Recalls (openFDA)
Biomet 3i: Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
- Recall number
- Z-0959-2007
- Recalling firm
- Biomet 3i
- Product
- Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
- Status
- Terminated
- Initiated
- 2007-05-14
- Posted
- 2007-06-19
- Terminated
- 2009-09-11
- Reason
- The depth indicator laser line markings on the drills are too faint for clinicians to read during use.
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 635699 and 652460
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28