FDA Medical Device Recalls (openFDA)
Biomet 3i: Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
- Recall number
- Z-0811-2007
- Recalling firm
- Biomet 3i
- Product
- Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
- Status
- Terminated
- Initiated
- 2007-04-25
- Posted
- 2007-05-16
- Terminated
- 2008-11-18
- Reason
- The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
- Root cause
- Other
- Action
- Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.
- Quantity
- 362 units
- Distribution
- Distributed worldwide, including USA, Spain and the Netherlands.
- Lot, serial or model codes
- lot Numbers: 593025-5, 593027-5, 598408-5, 593028-5, 599866-5 and 593029-5.
- 510(k) numbers
- ["K934126"]
- 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