Class II — restor3d Inc.
| Recalling firm | restor3d, inc. |
|---|---|
| Registered facility | restor3d, inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. |
| Product | 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 pol… |
| Quantity | 59 |
| Distribution | U.S. Nationwide distribution in the state of Texas. |
| Initiated | 2026-06-30 |
| Classified | 2026-08-19 |
| Recall number | Z-2987-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — restor3d Inc. (Z-2987-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99402/
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