Materialise N.V. recalls Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperati…

Recall date

July 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2886-2020

FDA classification

Class II

Brand / firm

Materialise N.V.

Sold / distributed

Nationwide distribution to: US including PR and International to UK and Australia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.