Materialise N.V. recalls TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
- Recall date
- February 3, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1484-2020
- FDA classification
- Class II
- Brand / firm
- Materialise N.V.
- Sold / distributed
- US: NY. OUS: Italy
Why it was recalled
Custom surgical kits contain a plate different than indicated by the package labeling.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
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