Veritas rTSA recallZ-2987-2026 · restor3d Inc. · initiated Jun 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from restor3d Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
FDA root cause category: Device Design
What the company is doing
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 Response Form (Attachment A) and return it to restor3d within 10 business days, whether or not affected product is in your possession, so that restor3d can confirm effective distribution of this notice. . Package the affected Veritas standard glenoid baseplates (1500-1030 and 1500-1035) to return to restor3d. restor3d has provided a prepaid FedEx shipping label by email for shipment back to 4001 NC-54 Hwy, Suite 2160 Durham, NC 27709. . Promptly report to restor3d any intraoperative issue, patient adverse event, suspected device related complication, loosening, migration, revision surgery, or other clinical concern potentially associated with the affected product.
Recall details
- Recall number
- Z-2987-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2026
- Posted by the FDA
- Aug 19, 2026
- Recalling firm
- restor3d Inc.
- Quantity
- 59
- Product code
- PHX
- FDA submissions
- K243643
- Distribution
- U.S. Nationwide distribution in the state of Texas.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Veritas rTSA 1500-1030Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall1 report
- Veritas rTSA 1500-1035Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K243643 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Veritas rTSA 3500-140C3Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration2 reports
- Veritas rTSA 3500-140U1Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration1 report
- Veritas rTSA 3500-140C1Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration1 report
- Veritas rTSA 3500-340U1Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration1 report
- Veritas rTSA 3500-536U3Restor3d, Inc. · Shoulder Prosthesis, Reverse Configuration1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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