—#178542

Product

Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - 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 product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K101909
Affected lot / code info: All lot numbers in OUS distribution.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

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.

Timeline

Recall initiated: 2019-12-03
Terminated: 2022-10-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.