TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Recall Z-1484-2020 · Posted None
Recalling FirmMaterialise N.V.
Recall StatusTerminated
Product CodeJEY
Date Initiated2020-02-03
Date Terminated2020-03-20
Product Quantity1
Reason for Recall
Custom surgical kits contain a plate different than indicated by the package labeling.
Root Cause
Employee error
Distribution Pattern
US: NY. OUS: Italy
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.