Exactech recalls specific shoulder implants due to incorrect label translations that may cause confusion about product size. Affected units include certain right humeral stems with 10.5mm size.
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.
“Exactech Equinoxe Shoulder Implant Recall: Incorrect Label Translations.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66407-exactech-equinoxe-shoulder-implant-recall-incorrect-label-translations. Based on FDA recall #Z-0873-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0873-2020%22&limit=1).
The FDA announced on 2019-12-03 that Exactech, Inc. is recalling Exactech equinoxe PLATFORM FRACTURE HUMERAL STEM implants due to labels with incorrect translations. The hazard involves the word "long" appearing on outer labels in languages other than English for standard length stems.
Distribution: International distribution in Australia; Austria; Brazil; Canada; China; Colombia; France; Germany; Guatemala; India; Italy; Japan; Luxembourg; Netherlands; Singapore; South Korea; Spain; Sweden; United Kingdom
The hazard
Labels with incorrect translations were identified by Exactech, 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.
Context
GovInfoNow's records show Exactech, Inc. has 34 other recalls on record since 2017-06-23. Other recent recalls of similar products include Equinoxe Ergo Ergo Modular Impactor Handle Recall (2026-02-03), Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm recall (2025-09-05), and Exactech Reverse Shoulder Humeral Liners Recall (2025-08-15). Other recent recalls of similar products include Encore Medical RSP Humeral Socket Insert Recall (2026-01-15), Micro Therapeutics Pipeline Flex Embolization Device (2026-06-08), and EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (2026-01-15).
How to tell if you have this one
Check for the Exactech Equinoxe shoulder implant with the model number REF 304-22-11 and size 10.5mm right humeral stem. The product was sold through OUS distribution channels.
Brand
Exactech
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0872-2020
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.; All lot numbers in OUS distribution.
2,910 devices
Z-0873-2020
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.; All lot numbers in OUS distribution.
N/A
Based on the official FDA remedy
What to do — step by step
Check Label Translation
Review the label for the word 'long' in the language of your label. If it's not English, this implant may be affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0873-2020 (December 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0873-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.