Device 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.
Z-2886-2020
Product summary
- Firm
- Materialise N.V.
- Event
- Event 86113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128
- Official record key
device-enforcement:Z-2886-2020
Official wording
Reason: 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.
Code information: ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
Distribution pattern: Nationwide distribution to: US including PR and International to UK and Australia.
Derived failure modes
-
Unknown
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.