Exactech Equinoxe Preserve Humeral Stem 8mm: Incorrect Instructions Risk
Exactech recalls Equinoxe Preserve Humeral Stem 8mm implants due to potential inclusion of Optetrak Knee System instructions instead of correct usage guide. Affected units have specific serial numbers and catalog codes.
Lower-risk recall
Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .
Contact the company
What happened, in plain English
Exactech is recalling Equinoxe Preserve Humeral Stem 8mm implants because some units may have been shipped with Optetrak Knee System instructions instead of the correct Equinoxe instructions. This could lead to improper use if the surgeon follows the wrong instructions. Read more at govinfonow.com/recall/69381-exactech-equinoxe-preserve-humeral-stem-8mm-incorrect-instructions-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69381-exactech-equinoxe-preserve-humeral-stem-8mm-incorrect-instructions-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0958-2019
Cite this page
“Exactech Equinoxe Preserve Humeral Stem 8mm: Incorrect Instructions Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69381-exactech-equinoxe-preserve-humeral-stem-8mm-incorrect-instructions-risk. Based on FDA recall #Z-0958-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2019%22&limit=1).
Why it’s dangerous
The recall involves a packaging error where some Equinoxe Preserve Humeral Stem 8mm implants were shipped with Optetrak Knee System instructions instead of the intended Equinoxe instructions. This could lead to improper surgical procedures if the surgeon follows the wrong instructions.
Who’s affected
Skeletally mature patients who received the Equinoxe Preserve Humeral Stem 8mm implant with serial numbers 5569566 through 5569595. Surgeons who used these implants are most at risk of administering incorrect instructions.
How to tell if you have this one
Check if your implant has serial numbers 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, or 5569595. The product catalog number is 300-30-08.
- Brand
Exactech- Category
Medical device
What to do — step by step
Check Your Implant
Verify your implant's serial number against the list: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
FDA distribution: “US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, Iowa, Louisiana, Maryland, Ohio, South Carolina.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0958-2019 (December 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0958-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.