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Materialise N.V. recalls Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraopera
Recalled September 2, 2020 · FDA recall Z-2886-2020 · 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. · FDA Class II
Units
128
Sold at
Nationwide distribution to: US including PR and International to UK and Australia.
Description
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.
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.
Manufacturer(s)
Materialise N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →