restor3d Inc.: 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 har

Is my product 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 patients

• UPC 00840097513225
• UPC 00840097513232

Check against the official notice below — it lists the full affected range.

What happened

Restor3d Inc. is recalling Veritas Standard Glenoid Baseplate components used in reverse total shoulder procedures. The recall affects 59 units distributed nationwide in Texas, specifically model numbers 1500-1030 and 1500-1035 with various lot codes. The devices have incorrect machining of peripheral screw holes that could result in improper engagement of the peripheral screws.

The recall notice does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. Distribution: U.S. Nationwide distribution in the state of Texas. Quantity: 59 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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