The Recall Desk

FDA (Devices) recall action 89592

Howmedica Osteonics Corp. recalled 2 products on 2022-04-06

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
2022-04-06
Critical
0
Units
—

Why these products were recalled

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2022-04-06

    Hip prosthetic femoral head component size and offset labeling mismatch

    Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.

    Product
    Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
    Category
    Distribution
    15 states
  • HighFDA (Devices)··2022-04-06

    Ceramic Hip Femoral Head Component May Not Match Package Label

    Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.

    Product
    Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
    Category
    Distribution
    15 states