PlainRecalls
FDA Devices Moderate Class II Terminated

TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

Reported: March 25, 2020 Initiated: February 3, 2020 #Z-1484-2020

Product Description

TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

Reason for Recall

Custom surgical kits contain a plate different than indicated by the package labeling.

Details

Recalling Firm
Materialise N.V.
Units Affected
1
Distribution
US: NY. OUS: Italy
Location
Heverlee

Frequently Asked Questions

What product was recalled?
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001. Recalled by Materialise N.V.. Units affected: 1.
Why was this product recalled?
Custom surgical kits contain a plate different than indicated by the package labeling.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1484-2020.