Equinoxe Ergo Reamer (Exactech) – Design Testing Incomplete (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Products Sold
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Exactech, Inc. is recalling Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321 due to Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and per. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
SC
Page updated: Jan 10, 2026