Match Point System The Match Point System is intended to by uses as a surgical instrument to a...
FDA Device Recall #Z-2886-2020 — Class II — July 17, 2020
Recall Summary
| Recall Number | Z-2886-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Materialise N.V. |
| Location | Heverlee, N/A |
| Product Type | Devices |
| 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.
Lot / Code Information
ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
Other Recalls from Materialise N.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2287-2023 | Class II | ProPlan CMF Patient-Specific Guide, Mandible gu... | Jun 19, 2023 |
| Z-2213-2023 | Class II | MRI Biomet Pin Guide for Total Knee Arthroplast... | Apr 26, 2023 |
| Z-1484-2020 | Class II | TRUMATCH Orthognathic - Full Bimaxillary Surgic... | Feb 3, 2020 |
| Z-1485-2020 | Class II | TRUMATCH Orthognathics - Genioplasty Surgical K... | Feb 3, 2020 |
| Z-0162-2016 | Class II | Signature Patient-Specific Surgical Guides; pat... | Sep 23, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.