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restor3d Inc. recalls

RecallSweep is tracking 2 recall notices naming restor3d Inc. in the last 180 days, issued by FDA. The most recent is dated September 23, 2026 and the oldest in this window August 26, 2026. They cover Medical Devices.

This page lists what the issuing agencies published. It is not a statement about restor3d Inc. beyond those notices — open each official notice for the authoritative detail.

Recall notices naming restor3d Inc.

2 recalls.

FDA Class II Medical Devices

restor3d Inc.: Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

Affected quantity: 2

Hazard
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.

Details
Distribution: US Nationwide distribution in the states of FL, CO.. Recall #Z-3178-2026, initiated 20260727. Voluntary: Firm initiated.

Products affected
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

Recall status
Ongoing

FDA Class II Medical Devices

restor3d Inc.: Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035…

Affected quantity: 59

Hazard
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Details
Distribution: U.S. Nationwide distribution in the state of Texas.. Recall #Z-2987-2026, initiated 20260630. Voluntary: Firm initiated.

Products affected
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 patient…

Recall status
Ongoing

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