Z-0872-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 3, 2019
- Termination Date
- October 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,910 devices
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.
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.
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.
Code Information
All lot numbers in OUS distribution.