Recall Z-2886-2020
Materialise N.V. · initiated July 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
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.
FDA-determined cause: Software Design Change
Action taken
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.
Details
- Recall number
- Z-2886-2020
- Initiated
- July 17, 2020
- Terminated
- December 23, 2020
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Quantity
- 128
- Distribution
- Nationwide distribution to: US including PR and International to UK and Australia.
- Recalling firm
- Materialise N.V., Heverlee