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FDA Closes Recall of restor3d Veritas Glenoid Baseplates

The agency has closed the Class II recall of certain Veritas Standard Glenoid Baseplates, citing completed corrective action.

2 reports on this incident · first at Sep 7, 2026, 8:19 p.m. ET

By AI ReporterWritten Sep 7, 2026, 8:23 p.m. ET
The U.S. Food and Drug Administration has closed the recall of certain restor3d Veritas Standard Glenoid Baseplates, recall number , according to an FDA enforcement report dated August 26, 2026. The agency considers the recall carried out. The recall, initiated June 30, 2026, covers 59 units of the Veritas Standard Glenoid Baseplate, models 1500-1030 and 1500-1035, distributed nationwide in Texas. The affected lot numbers are A00030, A00065, A09828, A09830 for model 1500-1030, and A00064, A09829 for model 1500-1035. The UDI-DI numbers are 00840097513225 and 00840097513232. The FDA classified the action as , meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The reason for the recall was incorrect machining of peripheral screw holes, which could lead to improper engagement of the peripheral screws. The Veritas Standard Glenoid Baseplate is a 3D-printed titanium alloy implant used in reverse shoulder replacement procedures, sold directly to healthcare facilities as a prescription device. , based in , NC, initiated the recall. The FDA database records no other enforcement action by this firm.

Earlier reports

  1. Sep 7, 2026, 8:19 p.m. ETFirst report

    restor3d Recalls Veritas Glenoid Baseplates Over Screw Hole Machining Issue

    restor3d Inc. of Durham, NC, initiated a recall of its Veritas Standard Reverse Total Shoulder glenoid baseplates on June 30, 2026, according to an FDA enforcement report dated August 26, 2026. The recall, listed as ongoing, affects 59 units distributed nationwide in Texas.

    The recall covers model numbers 1500-1030 and 1500-1035, with specific lot numbers A00030, A00065, A09828, A09830, A00064, and A09829. The affected products are identified by UDI-DI codes 00840097513225 and 00840097513232. The FDA classified the action as Class II, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote.

    The reason for the recall is incorrect machining of the peripheral screw hole, which could lead to improper engagement of the peripheral screws. The Veritas standard glenoid baseplate is the only component affected; the patient-specific baseplate is not in scope.

    The FDA database records no other enforcement action by restor3d. The recall is ongoing.

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Revision history

  1. Version 18 Sept 2026, 00:19current

    First published.

  2. Version 18 Sept 2026, 00:23current

    First published.

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