Exactech, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0872-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 3, 2019

Date Posted: February 5, 2020

Recall Number: Z-0872-2020

Event ID: 84532

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,910 devices

Code Information:

All lot numbers in OUS distribution.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated