FDA Medical Device Recalls (openFDA)
Implant Innovations, Inc.: EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
- Recall number
- Z-0029-05
- Recalling firm
- Implant Innovations, Inc.
- Product
- EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
- Status
- Terminated
- Initiated
- 2004-10-04
- Posted
- 2004-10-21
- Terminated
- 2005-02-07
- Reason
- The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
- Root cause
- Other
- Action
- Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.
- Quantity
- 216 units
- Distribution
- Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
- Lot, serial or model codes
- Product Code: THA54 Lot No. 249229
- 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