Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
- Company
- Exactech, Inc.
- Recall Initiated
- September 5, 2025
- Posted
- November 17, 2025
- Recall Number
- Z-0535-2026
- Quantity
- 1
- Firm Location
- Gainesville, FL
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.
Distribution
U.S.: SC O.U.S.: N/A
Lot / Code Info
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Root Cause
Release of Material/Component prior to receiving test results
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