Exactech, Inc. is recalling three specific Equinoxe Ergo surgical instruments, including 42mm and 46mm Adjustable Angle rTSA Reamers and a Pilot Tip Converter. These products were released and distributed before completing required design updates and performance testing. As a result, the tools may not conform to the manufacturer's intended design or performance standards. Only one unit of each specific catalog number is affected by this recall.
Using surgical tools that have not been fully tested and validated could lead to unexpected device behavior or failure during a procedure. This poses a risk of surgical delays or injury to the patient during orthopedic operations.
Manufacturer correction or return
Recall #: Z-0535-2026
Recall #: Z-0536-2026
Recall #: Z-0537-2026
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.