FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
- Recall number
- Z-1961-2013
- Recalling firm
- Biomet 3i, LLC
- Product
- Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
- Status
- Terminated
- Initiated
- 2013-05-10
- Posted
- 2013-08-13
- Terminated
- 2014-08-13
- Reason
- A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
- Root cause
- Labeling mix-ups
- Action
- The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.
- Quantity
- 33
- Distribution
- Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
- Lot, serial or model codes
- Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513
- 510(k) numbers
- ["K122300"]
- 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