FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
- Recall number
- Z-0298-2013
- Recalling firm
- Biomet 3i, LLC
- Product
- Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
- Status
- Terminated
- Initiated
- 2012-09-28
- Posted
- 2012-11-16
- Terminated
- 2015-08-06
- Reason
- Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
- Root cause
- Nonconforming Material/Component
- Action
- Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice.
- Quantity
- 76 devices
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
- Lot, serial or model codes
- Model Number IFOA411, Lot # 2011111333, 2011111333-S1
- 510(k) numbers
- K100724
- 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