FDA Medical Device Recalls (openFDA)
3m Imtec Corporation: S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
- Recall number
- Z-1703-2010
- Recalling firm
- 3m Imtec Corporation
- Product
- S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
- Status
- Terminated
- Initiated
- 2010-05-14
- Posted
- 2010-05-27
- Terminated
- 2010-07-14
- Reason
- Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.
- Root cause
- Packaging process control
- Action
- IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.
- Quantity
- 189 Implants
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot #035D10188
- 510(k) numbers
- ["K031106"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1000118617
- Firm city
- Ardmore
- Firm state
- OK
- 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