medical Class II Updated 2020-02-05

Exactech, Inc. recalls Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED,

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: International distribution in the countries of Australia; Austria; Brazil; Canada; China; Colombia: France; Germany; Guatemala, India; Italy; Japan; Luxembourg; Netherlands; Singapore; South Korea; Spain; Sweden: United Kingdom.
Lot/Code Info: All lot numbers in OUS distribution.
View official government recall

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