The Recall Desk

FDA (Devices) recall action 84532

Exactech, Inc. recalled 2 products on 2020-02-05

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
2020-02-05
Critical
0
Units
2,910

Why these products were recalled

Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.

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)··2020-02-05

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation

    Exactech is recalling Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.

    Product
    Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi-
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-02-05

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation

    Exactech is recalling 2,910 Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.

    Product
    Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- a
    Category
    Distribution
    0 states