FDA-Device2020-09-02Class II
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.
Materialise N.V.
Hazard
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.
Sold states
Nationwide distribution to: US including PR and International to UK and Australia.
Affected count
128
Manufactured in
Technologielaan 15, N/A, Heverlee, N/A, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2886-2020Don't want to check this manually?
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