Recall Z-0872-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
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.
| Date | Dec 3, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | The firm notified its direct accounts by email on 12/03/2019. The notice instructed the consignees to provide the field safety notice to all those within their organization or to any organization where the potentially affected device have been transferred. |
| Quantity | 2,910 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101909 | EXACTECH EQUINOXE, PLATFORM FRACTURE STEM Exactech, Inc., Aug 2, 2010 |