Z-0308-2021Class II

Equinoxe Platform Fracture Stem, 6.5mm, Right -

Name: Z-0308-2021 Equinoxe Platform Fracture Stem, 6.5mm, Right -
Creator: Exactech, Inc.
Published: 2020-09-25
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2020-09-25 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only on 2020-09-25. FDA classified it as Class II and gives the reason as "The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0308-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-25
Posted: 2020-10-29
Terminated: 2023-05-01
Recalling firm: Exactech, Inc.
Product: Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020. Consignees have been instructed to: -Immediately cease distribution or use of this product -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the Recall Inventory Response Form to Exactech.
Quantity in commerce: 12 devices
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
Product codes and lots: Catalog: 304-22-07; Serial Range: 4971292-4971303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0308-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0307-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-29
Z-0308-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-29

Product code PHX

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)