Exactech Equinoxe Humeral Stem 11mm: Incorrect Instructions Risk
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.
Lower-risk recall
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63953-exactech-equinoxe-humeral-stem-11mm-incorrect-instructions-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63953-exactech-equinoxe-humeral-stem-11mm-incorrect-instructions-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0884-2021
Cite this page
“Exactech Equinoxe Humeral Stem 11mm: Incorrect Instructions Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63953-exactech-equinoxe-humeral-stem-11mm-incorrect-instructions-risk. Based on FDA recall #Z-0884-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0884-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Orthopedic surgeons and medical professionals who use these implants during hip replacement surgery. Patients who have received this specific stem are also affected.
How to tell if you have this one
Check for the specific serial numbers listed: 6477393 through 6477407. Also look for the packaging lot number 49088921 and catalog number 300-01-11.
- Brand
Exactech- Category
Medical device
What to do — step by step
Contact Exactech
Reach out to Exactech for specific instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Kansas, Ohio.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0884-2021 (November 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0884-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.