FDA Medical Device Recalls (openFDA)
Materialise USA LLC: ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
- Recall number
- Z-1569-2022
- Recalling firm
- Materialise USA LLC
- Product
- ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
- Status
- Completed
- Initiated
- 2022-07-13
- Posted
- not on file
- Terminated
- not on file
- Reason
- MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
- Root cause
- Employee error
- Action
- Materialise USA LLC notified field representative via telephone on 13 July 2022 requesting the case to be returned. A replacement case was sent on 14 July 2022. Materialise picked up/received MU22-INQ-DUQ case with anatomical model MU22-NOF-SAK on 22 July 2022. This recall can be terminated as all distributed product (one case) has been returned to Materialise. No additional product remains in the field.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of MD.
- Lot, serial or model codes
- Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- 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