FDA Medical Device Recalls (openFDA)
Biomet 3i: Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
- Recall number
- Z-1221-2007
- Recalling firm
- Biomet 3i
- Product
- Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
- Status
- Terminated
- Initiated
- 2007-08-03
- Posted
- 2007-09-18
- Terminated
- 2009-09-11
- Reason
- The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
- Root cause
- Labeling mix-ups
- Action
- International customers were contacted first by e-mail , then by fax letter 08/03/2007.
- Quantity
- 240 (120 each model / lot)
- Distribution
- Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.
- Lot, serial or model codes
- Model No. LTX3211 - Packaged Lot No. 606199 Model No. LTX3213 - Packaged Lot No. 606191
- 510(k) numbers
- ["K063286","K950204"]
- 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