Exactech recalls Truliant Splined Stem Extension implants with a labeling error that shows 17mm x 80mm instead of 18mm x 120mm. This affects cemented total knee prosthesis systems.
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
Exactech is recalling Truliant Splined Stem Extensions that have a labeling error showing 17mm x 80mm instead of 18mm x 120mm. This error could lead to incorrect implant sizing during knee surgery, potentially causing complications.
The labeling error shows the implant size as 17mm x 80mm when it is actually 18mm x 120mm. This mismatch could lead to incorrect implant sizing during knee surgery, potentially causing complications like improper joint alignment or instability.
Patients who have received a Truliant Splined Stem Extension with the incorrect labeling (17mm x 80mm) are at risk of improper implant sizing during knee surgery. Surgeons and medical facilities using these implants are most affected.
Check the label on the Truliant Splined Stem Extension for the size listed as 17mm x 80mm instead of 18mm x 120mm. The product is used in cemented total knee prosthesis systems and has specific serial numbers: 6366405, 6367075, 6367076.
Verify the label shows 17mm x 80mm instead of 18mm x 120mm.
The label incorrectly shows the implant size as 17mm x 80mm when it is actually 18mm x 120mm.
Serial numbers 6366405, 6367075, and 6367076.
The error could lead to incorrect implant sizing during knee surgery, potentially causing complications like improper joint alignment or instability.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1364-2020 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1364-2020 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.
