Z-0536-2026Class II

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46...

Name: Z-0536-2026 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46...
Creator: Exactech, Inc.
Published: 2025-09-05
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2025-09-05 / Open, Classified / root cause: design

FDA source

Exactech, Inc. began a recall of Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA... on 2025-09-05. FDA classified it as Class II and gives the reason as "Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0536-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-05
Posted: 2025-11-17
Recalling firm: Exactech, Inc.
Product: Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Root cause tag: design
FDA root cause: Release of Material/Component prior to receiving test results
Action: On 09/05/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing that, during routine inventory review, it was discovered that the a number of parts/products, which were pending design verification testing were incorrectly placed in active internal inventory rather than designated quarantine locations. Several part/products were distributed to customers. Customers are instructed to: "Carefully review this notification to ensure that they fully understand the issue and all actions required. "Immediately identify, quarantine, and return any of the subject devices in their inventory and/or customer s inventory. "Stop and cease use of any affected devices. "Notify all their accounts that may have received these products and extend this recall notice, including the Description of Issue and Potential Clinical Impact, to them. "Complete and Return the attached Recall Inventory Response Form to Exactech via email at [email protected]. For questions or assistance - contact Recall Support Team at [email protected]
Quantity in commerce: 1
Distribution: U.S.: SC O.U.S.: N/A
Product codes and lots: Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0536-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0535-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-17
Z-0536-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-17
Z-0537-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-17

Product code PHX

K042021Class IIExactech Equinoxe Shoulder SystemExactech, Inc. / cleared 2004-10-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)