Device recall
Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
- Recall number
- Z-0348-2027
- Event id
- 100047
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- restor3d Inc.
- Posted
- Nov 3, 2026
- Initiated
- Oct 1, 2026
- Product code
- PHX
- Device type
- Shoulder Prosthesis, Reverse Configuration
- Reason
- (Retroactively reported) Pairing of shoulder implant stem sizes 1 and 2 with the largest glenosphere diameter (40 mm) creates an excessive mechanical loading configuration in which certain polyethylene components lack adequate retention strength, potentially resulting in dislocation, reduced range of motion, or revision surgery.
- Root cause
- Device Design
- Quantity
- 240 units
- Code info
- All Lot codes/ UDIs:Product Code: 3500-140C3 UDI/GTIN:00840097513492; Product Code: 3500-140U3 UDI/GTIN:00840097513461; Product Code: 3500-140C1 UDI/GTIN:00840097513430; Product Code: 3500-140U1 UDI/GTIN:00840097513409
- Distribution
- US Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina.
- Related 510(k)s
- K243643
- Location
- Durham, NC