FDA Enforcement
Class II
Terminated
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.
Recall: Z-2886-2020
·
Reported September 2, 2020
Enforcement
- Recall Number
- Z-2886-2020
- Event ID
- 86113
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Materialise N.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 2, 2020
- Initiation Date
- July 17, 2020
- Classification Date
- August 26, 2020
- Termination Date
- December 23, 2020
- Address
- Technologielaan 15, N/A, Heverlee, N/A, N/A, Belgium
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
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 Info
ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
Distribution
Nationwide distribution to: US including PR and International to UK and Australia.
Quantity
128