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U.S. Department of Health and Human Services

Class 2 Device Recall Veritas Reverse Total Shoulder Replacement

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 Class 2 Device Recall Veritas Reverse Total Shoulder Replacementsee related information
Date Initiated by FirmOctober 01, 2026
Date PostedNovember 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0348-2027
Recall Event ID 100047
510(K)NumberK243643 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
Code Information 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
FEI Number 3014833750
Recalling Firm/
Manufacturer		 restor3d Inc.
4001 E Nc 54 Hwy
Suite 3160
Durham NC 27709
For Additional Information ContactBrianna Gabbard
1-786-5210501
Manufacturer 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 Determined
Cause 2		Device Design
ActionOn 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 Commerce240 units
DistributionUS Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PHX
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