Z-0872-2020Class II

Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 -

Name: Z-0872-2020 Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 -
Creator: Exactech, Inc.
Published: 2019-12-03
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2019-12-03 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of 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... on 2019-12-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0872-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-03
Posted: 2020-01-28
Terminated: 2022-10-11
Recalling firm: Exactech, Inc.
Product: 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.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All lot numbers in OUS distribution.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0872-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0872-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28
Z-0873-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28

Product code PHX

K101909Class IIExactech Equinoxe, Platform Fracture StemExactech, Inc. / cleared 2010-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)