Exactech, Inc.: 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.

Agency Publication Date: January 28, 2020

Affected Products

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- arthroplasty is determined by the surgeon to be the preferred method of treatment.

All lot numbers in OUS distribution.

Lot Numbers:

numbers

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- arthroplasty is determined by the surgeon to be the preferred method of treatment.

All lot numbers in OUS distribution.

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84532

Status: Resolved

Manufacturer: Exactech, Inc.

Manufactured In: United States

Units Affected: 2,910 devices

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Sources: FDA iRES · Raw API Response

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Affected Products

All lot numbers in OUS distribution.

Lot Numbers:

numbers

All lot numbers in OUS distribution.

Lot Numbers:

numbers