Recall Z-0348-2027 ยท PHX Shoulder Prosthesis, Reverse Configuration
restor3d Inc.
Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
| Date | Nov 3, 2026 (initiated Oct 1, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On 1, 2026 Restor3d reached out to affected consignees via phone call to make them aware of the recall. A Urgent; Medical Device Recall was issued to affected consignees on October 7, 2026 via email. Restor3d ask consignees to take the following actions: 1. Do not implant or otherwise use any affected units identified above. 2. Complete the attached Field Action Response Form (Attachment A) and return it to restor3d within 10 business days, so that restor3d can confirm effective distribution of this notice. 3. Promptly report to restor3d any intraoperative issue, patient adverse event, su |
| Quantity | 240 units |
| Distribution | US Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System Restor3D, May 19, 2025 |