FDA Device recall Z-2886-2020
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of gl…
- FDA Device
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of gl… by Materialise N V, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2886-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-17 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Materialise N V |
| Distribution | US |
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.
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.
Identifiers
| code_info | ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2886-2020%22
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