Exactech recalls specific Truliant Tibial Fit Trays (cemented SZ 3F/3T) due to mismatched labels. This affects certain knee replacement implants sold with serial numbers starting 5774515-5774543. No immediate action is needed as the mismatch is cosmetic and does not affect safety.
2.5 Truliant Fit Trays were mismarked as 3
Exactech recalls certain Truliant Tibial Fit Trays used in knee replacements because they were incorrectly labeled as size 3 instead of size 3F or 3T. This mismatch does not cause injury or safety issues but may lead to confusion during surgery.
The Truliant Fit Trays were mismarked as size 3 when they should have been size 3F or 3T. This labeling error could cause confusion during surgery but does not pose a direct safety risk to patients or the surgical process.
Patients who received knee replacement implants with serial numbers starting 5774515 to 5774543 are likely affected. Surgeons and medical staff using these specific implants during procedures may also be impacted.
Check the serial number on your Truliant Tibial Fit Tray for the range 5774515 to 5774543. The product is used in knee joint replacements and has a specific catalog number (02-022-45-3030).
Verify your Truliant Tibial Fit Tray's serial number to see if it falls within the range 5774515 to 5774543.
No, the mismatched labeling does not pose a safety risk. You can continue using the product as normal.
Check the serial number to see if it is in the range 5774515 to 5774543. If so, contact Exactech for more information.
No, the recall is for labeling accuracy only and does not affect patient safety or surgical outcomes.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1208-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1208-2019 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.
