Equinoxe recallZ-0537-2026 · Exactech, Inc. · initiated Sep 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Release of Material/Component prior to receiving test results
What the company is doing
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]
Recall details
- Recall number
- Z-0537-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 5, 2025
- Posted by the FDA
- Nov 17, 2025
- Recalling firm
- Exactech, Inc.
- Quantity
- 1
- Product code
- PHX
- FDA submissions
- K042021
- Distribution
- U.S.: SC O.U.S.: N/A
Product description
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
Code information (models, lots, serial numbers)
Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Equinoxe 301-11-11Exactech, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
Product lines
Other devices under the same FDA submission
72 devices cleared under K042021 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Equinoxe 300-01-11Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall44 reports
- Equinoxe 314-02-02Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall10 reports
- Equinoxe 314-02-14Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall8 reports
- Equinoxe 314-02-03Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall4 reports
- Equinoxe 314-02-13Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall4 reports
- Equinoxe 314-01-02Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall2 reports
- Equinoxe 314-01-13Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall2 reports
- Equinoxe 314-02-04Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall1 report
- Equinoxe 314-01-03Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
- Equinoxe 314-01-04Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-01-12Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
- Equinoxe 314-01-14Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97588).
- Z-0535-2026 · Open, ClassifiedBrand 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: N…
- Z-0536-2026 · Open, ClassifiedBrand 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: N…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page