FDA recall, , Moderate risk
restor3d Veritas Reverse Total Shoulder Replacement
The Veritas Reverse Total Shoulder Replacement can dislocate, reduce range of motion, or lead to revision surgery.
Summary by Recall Canary from the FDA notice
What happened
restor3d Inc., of Durham, North Carolina, is voluntarily recalling the Veritas Reverse Total Shoulder Replacement, size 1-2, 40mm Polymer Liner. The FDA reported that pairing 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.
The firm initiated the recall on October 1, 2026, and the FDA added it to the Enforcement Report on November 3, 2026. The product was distributed in Texas, Massachusetts, Oklahoma, Florida, Colorado, and North Carolina, and customers were notified by e-mail.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Veritas Reverse Total Shoulder Replacement
- Model number
- 3500-140C3
- 3500-140U3
- 3500-140C1
- 3500-140U1
- Lot code
- 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
From the FDA notice
Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
US Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina.
- Recalled by
- restor3d Inc.Durham, North Carolina
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100047
- Recall number
- Z-0348-2027
- Quantity recalled
- 240 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from restor3d Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
restor3d began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
