Device recall
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
- Recall number
- Z-2987-2026
- Event id
- 99402
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- restor3d Inc.
- Report date
- Aug 26, 2026
- Posted
- Aug 19, 2026
- Initiated
- Jun 30, 2026
- Center classification date
- Aug 19, 2026
- Product code
- PHX
- Device type
- Shoulder Prosthesis, Reverse Configuration
- Reason
- Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- Root cause
- Device Design
- Quantity
- 59
- Code info
- 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
- Distribution
- U.S. Nationwide distribution in the state of Texas.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K243643
- Location
- Durham, NC, United States