Z-2886-2020 Class II Terminated
FDA device recall Z-2886-2020 was initiated by Materialise N.V. on Jul 17, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Dec 23, 2020). Affected quantity: 128.
Recall details
- Product Type
- Devices
- Report Date
- Sep 2, 2020
- Initiation Date
- Jul 17, 2020
- Termination Date
- Dec 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128
Product description
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 for recall
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.
Distribution pattern
Nationwide distribution to: US including PR and International to UK and Australia.
Code information
ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2886-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026