Materialise N.V. Technologielaan 15 Heverlee Belgium TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Brand
Materialise N.V. Technologielaan 15 Heverlee Belgium
Lot Codes / Batch Numbers
Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK
Products Sold
Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK
Materialise N.V. Technologielaan 15 Heverlee Belgium is recalling TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 due to Custom surgical kits contain a plate different than indicated by the package labeling.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
Custom surgical kits contain a plate different than indicated by the package labeling.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY
Page updated: Jan 10, 2026