Recall Z-2987-2026 ยท PHX Shoulder Prosthesis, Reverse Configuration
restor3d Inc.
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
| Date | Aug 19, 2026 (initiated Jun 30, 2026) |
| Status | Open, Classified |
| Reason | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. |
| Root cause | Device Design |
| Action | On 06/30/2027 and 07/02/2026, emailed an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter informing customers that, restor3d has identified a machining nonconformance affecting the peripheral screw holes on certain Veritas standard glenoid baseplates. Customers are instructed to: Immediately upon receipt of this notice: .Do not implant or otherwise use any affected units identified above. .Quarantine all affected, unused units identified above and remove them from implant sets, consignment inventory, inventory shelves, and any other storage locations. . Complete the attached Field Action Resp |
| Quantity | 59 |
| Distribution | U.S. Nationwide distribution in the state of Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System Restor3D, May 19, 2025 |