Recall Z-2886-2020— Materialise N.V.
Class II · Terminated
Class II FDA medical device recall by Materialise N.V., initiated 2020-07-17, terminated 2020-12-23. It names 2 FDA 510(k) clearances: K170893, K153602. 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..
- Recalling firm
- Materialise N.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-17
- Terminated
- 2020-12-23
- Firm location
- Heverlee, N/A, Belgium
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.