Veritas Standard Reverse Total Shoulder Product Name recall

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

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 bear…

Quantity: 59

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

restor3d Inc., Durham, NC

Date

Wednesday, August 26

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
U.S. Nationwide distribution in the state of Texas.

Status

Ongoing

Recall number

Z-2987-2026

Source

U.S. Food and Drug Administration