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
Recall
- Recall Number
- Z-0536-2026
- Event Number
- 97588
- Firm
- Exactech, Inc.
- FEI Number
- 1038671
- Product Code
- PHX
- Status
- Open, Classified
- Root Cause
- Release of Material/Component prior to receiving test results
- Initiated
- September 5, 2025
- Posted
- November 17, 2025
- Address
- 2320 Nw 66th Ct, Gainesville, FL, 32653-1630
Description
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
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
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]
U.S.: SC O.U.S.: N/A
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