The Recall Desk

FDA (Devices) recall action 77479

Exactech, Inc. recalled 2 products on 2017-12-13

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
2017-12-13
Critical
0
Units
18

Why these products were recalled

Possible inner labeling and packaged device not matching the outer label on the box.

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

  • ModerateFDA (Devices)··2017-12-13

    Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch

    Exactech, Inc. is recalling nine Vantage Total Ankle Tibial Inserts because the inner labeling and packaged device may not match the outer box label.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where suffi
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-12-13

    Exactech Vantage Total Ankle Tibial Insert Recalled for Labeling Mismatch

    Exactech is recalling nine Vantage Total Ankle Tibial Inserts due to possible mismatches between inner and outer packaging labels.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where su
    Category
    Distribution
    1 state