FDA Medical Device Recalls (openFDA)
Implant Innovations, Inc.: LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile
- Recall number
- Z-0665-03
- Recalling firm
- Implant Innovations, Inc.
- Product
- LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
- Status
- Terminated
- Initiated
- 2003-01-28
- Posted
- 2003-03-20
- Terminated
- 2012-05-03
- Reason
- Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
- Root cause
- Other
- Action
- The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.
- Quantity
- 68
- Distribution
- Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.
- Lot, serial or model codes
- For LTX 611 lot number 150102P For LTX 515 lot number 150100P
- 510(k) numbers
- ["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