Materialise N.V.: Medical Device Recall in 2020 - (Recall #: Z-2886-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class II
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.
ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
Nationwide distribution to: US including PR and International to UK and Australia.
Voluntary: Firm initiated