Recall Z-0536-2026 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
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
| Date | Nov 17, 2025 (initiated Sep 5, 2025) |
| Status | Open, Classified |
| Reason | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Root 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 |
| Quantity | 1 |
| Distribution | U.S.: SC O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042021 | EXACTECH EQUINOXE SHOULDER SYSTEM Exactech, Inc., Oct 26, 2004 |