FDA Medical Device Recalls (openFDA)
Materialise USA LLC: ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
- Recall number
- Z-0577-2014
- Recalling firm
- Materialise USA LLC
- Product
- ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
- Status
- Terminated
- Initiated
- 2013-11-08
- Posted
- 2013-12-26
- Terminated
- 2014-01-07
- Reason
- Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
- Root cause
- Labeling Change Control
- Action
- Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.
- Quantity
- 1
- Distribution
- Distributed in Canada.
- Lot, serial or model codes
- Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3005718816
- Firm city
- Plymouth
- Firm state
- MI
- 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