Reported Mar 25, 2020 · Terminated
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Materialise N.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise N.V. · Technologielaan 15 · Heverlee · N/A
Is this the product you have?
- TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on
- Catalog NumberSD980.013
- Lot codes and dates
- Lot NumberME19-ZIK-VIK
- UDI(01)05420060380136(10)ME19ZIKVIK
- Amount recalled
- 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Custom surgical kits contain a plate different than indicated by the package labeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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