Recall Weekly
Moderate riskFDA DeviceClass II

restor3d Veritas shoulder implants recalled for dislocation risk

restor3d Inc. recalled certain Veritas Reverse Total Shoulder Replacement implants, sizes 1 and 2 with the 40 mm polymer liner. The FDA says this pairing may leave some polyethylene components without adequate retention strength, potentially causing dislocation, reduced range of motion, or revision surgery. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Restor3d recalls

What to do

  1. Surgeons and hospitals: set aside affected units, catalog numbers 3500-140C3, 3500-140U3, 3500-140C1 and 3500-140U1 (UDIs 00840097513492, 00840097513461, 00840097513430, 00840097513409).
  2. Contact restor3d Inc. about the affected units and next steps.
  3. Patients with this implant: contact your surgeon or care team; don't stop or change your care on your own.
  4. The notice doesn't say what remedy is available; ask restor3d Inc. or your surgeon.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

Details

Units affected
240 units
Illnesses reported
None reported
Manufactured in
4001 E Nc 54 Hwy, Suite 3160, Durham, North Carolina, United States
Classification
Class II
Recall number
Z-0348-2027

In the FDA's words

Description
Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner (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. 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 Distribution: US Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina. Affected quantity: 240 units
Hazard
(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.

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