Class 2 Device Recall Equinoxe Ergo

• Date Initiated by Firm: September 05, 2025
• Date Posted: November 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0536-2026
• Recall Event ID: 97588
• 510(K)Number: K042021
• Product Classification: shoulder prosthesis, reverse configuration - Product Code PHX
• 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
• Code Information: Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Darin Johnson; +1-352-377-1140
• Manufacturer 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.
• FDA Determined 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 recalls@exac.com. For questions or assistance - contact Recall Support Team at recalls@exac.com
• Quantity in Commerce: 1
• Distribution: U.S.: SC O.U.S.: N/A
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PHX