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.
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 .
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.
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.
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.
Check if your implant has serial numbers 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, or 5569595. The product catalog number is 300-30-08.
Verify your implant's serial number against the list: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.
Exactech found that some Equinoxe Preserve Humeral Stem 8mm implants were inadvertently packaged with Optetrak Knee System instructions instead of the correct Equinoxe instructions.
Check your implant's serial number against the list provided. If it matches, contact Exactech for guidance.
The risk is low as this is a packaging error that could lead to improper instructions if followed, but does not cause immediate harm.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0958-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0958-2019 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.
