Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog…

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• Brand NameVeritas Standard
• Reverse Total Shoulder Product NameVeritas Standard
• Glenoid Baseplate Model/Catalog Number
  • 1500-1030
  • 1500-1035
• Software VersionN/A - off-the-shelf
• hardware product Product DescriptionThe 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 bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope
• ComponentReverse Total Shoulder

Lot codes and dates

• Lot Code
  • Model No 1500-1030
  • UDI-DI 00840097513225
  • Lot Numbers A00030
  • A00065
  • A09828
  • A09830 Model No 1500-1035
  • UDI-DI 00840097513232
  • Lot Numbers A00064
  • A09829

Amount recalled

59

Where it was sold

• Nationwide
• TX

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.