The Recall Desk

FDA (Devices) recall action 74317

Exactech, Inc. recalled 2 products on 2016-07-13

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
2016-07-13
Critical
0
Units
22

Why these products were recalled

Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

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.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2016-07-13

    Exactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling

    Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.

    Product
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis…
    Category
    Distribution
    4 states
  • LowFDA (Devices)··2016-07-13

    Exactech Recalls Hip Replacement Stems Due to Incorrect GTIN Labeling

    Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).

    Product
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis…
    Category
    Distribution
    4 states