Z-0348-2027

Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1...

Name: Z-0348-2027 Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1...
Creator: restor3d Inc.
Published: 2026-10-01
License: https://open.fda.gov/license/

restor3d Inc. / initiated 2026-10-01 / Open, Classified

FDA source

Recall record

Recall number: Z-0348-2027
Status: Open, Classified
Initiated: 2026-10-01
Posted: 2026-11-03
Recalling firm: restor3d Inc.
Product: Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: (Retroactively reported) Pairing of shoulder implant stem sizes 1 and 2 with the largest glenosphere diameter (40 mm) creates an excessive mechanical loading configuration in which certain polyethylene components lack adequate retention strength, potentially resulting in dislocation, reduced range of motion, or revision surgery.
FDA root cause: Device Design
Action: On 1, 2026 Restor3d reached out to affected consignees via phone call to make them aware of the recall. A Urgent; Medical Device Recall was issued to affected consignees on October 7, 2026 via email. Restor3d ask consignees to take the following actions: 1. Do not implant or otherwise use any affected units identified above. 2. Complete the attached Field Action Response Form (Attachment A) and return it to restor3d within 10 business days, so that restor3d can confirm effective distribution of this notice. 3. Promptly report to restor3d any intraoperative issue, patient adverse event, suspected device related complication, loosening, migration, revision surgery, or other clinical concern potentially associated with the affected product.
Quantity in commerce: 240 units
Distribution: US Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina.
Product codes and lots: All Lot codes/ UDIs:Product Code: 3500-140C3 UDI/GTIN:00840097513492; Product Code: 3500-140U3 UDI/GTIN:00840097513461; Product Code: 3500-140C1 UDI/GTIN:00840097513430; Product Code: 3500-140U1 UDI/GTIN:00840097513409

Product code PHX

K243643Class IIrestor3d Reverse Total Shoulder Arthroplasty SystemRestor3D / cleared 2025-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)