Exactech recalls specific Truliant Knee System models due to vacuum bag loss. Affected units have catalog numbers and serial numbers listed. Consumers should contact Exactech for details.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling certain Truliant Knee System implants because they may lose vacuum in the innermost bag. This could lead to improper function during surgery. Affected patients should contact Exactech for guidance.
The innermost vacuum bag in the implant may lose vacuum, causing the implant to not function properly during surgery. This could lead to improper placement or complications.
Patients who received the recalled Truliant Knee System implants between the dates listed in the catalog numbers and serial numbers. Surgeons and medical staff using these specific models are most at risk.
Check the catalog numbers (a) 02-012-35-3509, (b) 02-022-35-1509, (c) 02-022-35-1513, and (d) 02-022-35-3010) and serial numbers listed in the recall notice. The product was sold with specific GTINs and serial numbers.
Reach out to Exactech directly for specific instructions on how to verify your product and get assistance.
The recall affects Exactech Truliant Knee System models with catalog numbers a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, and d) 02-022-35-3010, along with specific serial numbers listed in the notice.
Check the catalog number and serial number on your implant against the list provided in the recall notice, which includes specific GTINs and serial numbers.
Contact Exactech directly for guidance on next steps, as the recall does not include a specific remedy like replacement or repair.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0585-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0585-2024 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.
