—#216007

Product

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

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042021
Affected lot / code info: Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001

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.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

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

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: U.S.: SC O.U.S.: N/A

Timeline

Recall initiated: 2025-09-05
Posted by FDA: 2025-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.