The Recall Desk

FDA (Devices) recall action 79321

United Orthopedic Corporation recalled 2 products on 2018-03-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-03-28
Critical
0
Units
83

Why these products were recalled

UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2018-03-28

    United Orthopedic Recalls U2 Total Knee System Tibial Inserts Due to Labeling Mismatch

    United Orthopedic Corporation is recalling 69 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.

    Product
    U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-03-28

    United Orthopedic Recalls U2 Total Knee System Tibial Inserts

    United Orthopedic Corporation is recalling 14 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.

    Product
    U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to
    Category
    Distribution
    0 states