Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Basep...
FDA Device Recall #Z-2987-2026 - Class II, June 30, 2026
Recall Summary
| Recall Number | Z-2987-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 30, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | restor3d Inc. |
| Location | Durham, NC |
| Product Type | Devices |
| Quantity | 59 |
Product Description
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder
Reason for Recall
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Distribution Pattern
U.S. Nationwide distribution in the state of Texas.
Lot / Code Information
Lot Code: Model No 1500-1030; UDI-DI 00840097513225; Lot Numbers A00030, A00065, A09828, A09830 Model No 1500-1035; UDI-DI 00840097513232; Lot Numbers A00064, A09829
Other Recalls from restor3d Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1027-2022 | Class II | Evans Wedge Disposable Trials, Medium Footprint... | Mar 30, 2022 |
| Z-1026-2022 | Class II | Non-Sterile Double Ended Trial Kit, Small Footp... | Mar 30, 2022 |
| Z-1028-2022 | Class II | Evans Wedge Disposable Trials, Large Footprint,... | Mar 30, 2022 |
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.