Exactech recalls Equinoxe Ergo Pilot Tip Converter model 301-11-11 due to incomplete design updates and performance testing. Products may not meet safety standards.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Exactech is recalling Equinoxe Ergo Pilot Tip Converters with model number 301-11-11 because they were released without completing necessary design updates and performance testing. This could mean the products don't meet safety standards, but there's no mention of specific injury risks or immediate action needed.
The product was released without completing required design updates and performance testing. This could mean the device doesn't meet safety standards, but the recall doesn't specify how this might cause harm or injury.
Users of the Equinoxe Ergo Pilot Tip Converter model 301-11-11 are likely affected. Those using medical devices that require this component may be at higher risk.
Check for the model number 301-11-11 on the product. The product was sold with lot code 410413-001 and part number 301-11-11.
Verify the model number is 301-11-11 and lot code 410413-001 to confirm if the product is recalled.
The recall states the product may not conform to design and performance criteria, but it does not specify any injury risks.
The recall does not provide a remedy, so no specific action is required beyond checking if you have the model 301-11-11.
The recall mentions the product was released without completing design updates and performance testing, but it does not specify software updates.
We’ve drafted a message you can send Equinoxe Ergo to request your refund or repair — edit it as you like.
Subject: Recall Z-0537-2026 — Equinoxe Ergo Equinoxe Ergo Hello, I own a Equinoxe Ergo that is covered by recall Z-0537-2026 from Equinoxe Ergo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
