medical Class II Updated 2020-09-02

Materialise N.V. recalls Match Point System The Match Point System is intended to

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
View official government recall

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