# Oped Canada Distribution · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Oped Canada Distribution · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is Matrix II; Bone Growth Stimulator | Matrix II; Bone Growth Stimulator; product code is 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive; date published is 09/16/2009; address is 344 Townsend Ave , Burlington, ON CANADA, verified against its source on 2026-09-16.

- **Firm:** Oped Canada Distribution _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 344 Townsend Ave , Burlington, ON CANADA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive _(verified: each item appears in the quote below)_
- **Product:** Matrix II; Bone Growth Stimulator | Matrix II; Bone Growth Stimulator _(verified: each item appears in the quote below)_
- **FDA notes:** The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 | The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 _(verified: each item appears in the quote below)_

## What the source says

> Oped Canada Distribution Date Published : 09/16/2009 344 Townsend Ave , Burlington, ON CANADA 87 L - - OE Stimulator, invasive bone growth Date Published: 06/04/2019 Desc: Matrix II; Bone Growth Stimulator Notes: The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 87 L - - OF Stimulator, bone growth, non-invasive Date Published: 06/04/2019 Desc: Matrix II; Bone Growth Stimulator Notes: The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).