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.
FDA Recall Z-0872-2020 · Posted None
Advertisement
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodePHX
Date Initiated2019-12-03
Date Terminated2022-10-11
Product Quantity2,910 devices
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.
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.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement