United StatesThe Veritas Standard Reverse Total Shoulder glenoid baseplate (models 1500-1030 and 1500-1035; Lot A00030, A00065, A09828, A09830, A00064, A09829; UDI‑DI 00840097513225 and 00840097513232), 59 units distributed in Texas, is affected. It was recalled because incorrect machining of a peripheral screw hole can result in potential improper engagement of the peripheral screws.
What's being recalled
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…
Recalling firm: restor3d Inc., Durham, NC, United States.
How to identify it
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
The hazard
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the state of Texas.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)