Z-2987-2026Class II

Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate...

Name: Z-2987-2026 Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate...
Creator: restor3d Inc.
Published: 2026-06-30
License: https://open.fda.gov/license/

restor3d, Inc. / initiated 2026-06-30 / Open, Classified / root cause: design

FDA source

restor3d Inc. began a recall of Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software... on 2026-06-30. FDA classified it as Class II and gives the reason as "Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2987-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-30
Posted: 2026-08-19
Recalling firm: restor3d, Inc.
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 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
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 59
Distribution: U.S. Nationwide distribution in the state of Texas.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2987-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2987-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-19

Product code PHX

K243643Class IIrestor3d Reverse Total Shoulder Arthroplasty SystemRestor3D / cleared 2025-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)