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

FDA device recall Z-0536-2026 · posted 2025-11-17 · Open, Classified

Recall details

Recalling firm

Exactech, Inc.

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.

Action taken

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 recalls@exac.com. For questions or assistance - contact Recall Support Team at recalls@exac.com

Root cause

Release of Material/Component prior to receiving test results

Status

Open, Classified

Product code

PHX

Quantity affected

1

Distribution

U.S.: SC O.U.S.: N/A

Date initiated

2025-09-05

Date posted

2025-11-17

Location

Gainesville, FL

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