Recall Z-2886-2020 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Materialise N.V.
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.
| Date | Jul 17, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Software Design Change |
| Action | The firm, materialise, sent Recall letters dated 17 July 2020 informing customers of the issue. This letter informs the customer that Materialise has corrected the Shoulder Case Planning Report in the SurgiCase online system. If you have any questions, contact Global Quality and Regulatory Manager Medical, at 734-259-7017 or email: Jenny.Jones@materialise.com. |
| Quantity | 128 |
| Distribution | Nationwide distribution to: US including PR and International to UK and Australia. |
| FDA record | Open on fda.gov |