Materialise N.V. Technologielaan 15 Heverlee Belgium Recalls

FDA
2
Total Recalls
1
Agencies
Mar 2020
First Recall
Dec 2020
Latest Recall
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Showing 1-2 of 2 recalls

FDA

Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.

The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

The firm, materialise, sent Recall letters dated 17 July 2020 informing customers of the issue. This letter informs the customer that Materialise has corrected the Shoulder Case Planning Report in the SurgiCase online system. If you have any questions, contact Global Quality and Regulatory Manager Medical, at 734-259-7017 or email: Jenny.Jones@materialise.com.
FDA

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

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