FDA Medical Device Recalls (openFDA)
Materialise N.V.: TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
- Recall number
- Z-1485-2020
- Recalling firm
- Materialise N.V.
- Product
- TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
- Status
- Terminated
- Initiated
- 2020-02-03
- Posted
- not on file
- Terminated
- 2020-03-20
- Reason
- Custom surgical kits contain a plate different than indicated by the package labeling.
- Root cause
- Employee error
- Action
- not on file
- Quantity
- 1
- Distribution
- US: NY. OUS: Italy
- Lot, serial or model codes
- Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK
- 510(k) numbers
- ["K170272"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 3003998208
- Firm city
- Heverlee
- Firm state
- not on file
- Firm country
- Belgium
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