Exactech recalls 11mm Equinoxe Humeral Stems with potential for incorrect Instructions for Use. Affected units include specific serial numbers and packaging lots. Consumers should contact Exactech for details.
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Exactech is recalling 11mm Equinoxe Humeral Stems due to a risk of incorrect Instructions for Use being included with the product. This could lead to improper surgical application if the instructions are not followed correctly.
The recall is for a potential issue with the Instructions for Use (IFU) included with the product. If the instructions are incorrect, it could lead to improper surgical application during hip replacement procedures.
Orthopedic surgeons and medical professionals who use these implants during hip replacement surgery. Patients who have received this specific stem are also affected.
Check for the specific serial numbers listed: 6477393 through 6477407. Also look for the packaging lot number 49088921 and catalog number 300-01-11.
Reach out to Exactech for specific instructions on how to handle the recalled product.
Exactech recalls these 11mm Equinoxe Humeral Stems due to a potential for incorrect Instructions for Use being included with the product.
Check for the specific serial numbers: 6477393 through 6477407, packaging lot number 49088921, or catalog number 300-01-11.
Contact Exactech directly for specific instructions on handling the recalled product.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0884-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0884-2021 from Exactech. 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.
