Exactech recalls Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm (model 321-59-46) 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 Adjustable Angle rTSA Reamer, 46mm models (321-59-46) because they were released without completing necessary design updates and performance testing. This could mean the products don't meet safety standards.
The recall states that products were released without completing design updates and performance testing. This could mean the instruments don't meet safety standards, but the specific risk isn't detailed in the notice.
Users of this dental surgical instrument are affected. Dentists and dental technicians who own or use the recalled model are most at risk.
Check for the model number 321-59-46 on the product. The product is an adjustable angle rTSA reamer used in dental procedures.
Identify the model number 321-59-46 on the product to confirm if it's recalled.
The recall states that products were released without completing design updates and performance testing, which may mean they don't meet safety standards.
Check for the model number 321-59-46 on the product. This is an adjustable angle rTSA reamer used in dental procedures.
The recall notice does not specify a remedy, so no action is required beyond checking if your product matches the model number.
We’ve drafted a message you can send Equinoxe Ergo to request your refund or repair — edit it as you like.
Subject: Recall Z-0536-2026 — Equinoxe Ergo Equinoxe Ergo Hello, I own a Equinoxe Ergo that is covered by recall Z-0536-2026 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.
