Exactech recalls specific Vantage Total Ankle Tibial Insert models due to incorrect size labeling on the implant. The label shows size 3 but the actual size is 4. This may cause improper fitting. No action is required as the error is not dangerous.
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
Exactech is recalling a specific ankle implant model due to a labeling error where the size is incorrectly listed as 3 instead of 4. This could lead to improper fitting if used without correction, but the error does not pose an immediate safety risk.
The label incorrectly states the implant size as 3 when it is actually size 4. This could lead to improper fitting if the implant is used without correction, potentially causing complications during surgery or post-operative care. However, the error does not cause immediate injury or harm in normal use.
Patients who received the recalled Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm implant with the specific lot and serial numbers listed in the recall notice. Orthopedic surgeons and medical staff who use this implant are most at risk of administering the wrong size.
Check the label on the implant for the size listed in the upper right corner. The recalled model has a label that says '3' but the actual size is 4. The specific lot numbers (05144883, 05144884) and serial numbers (6417984, 6417989, etc.) are listed in the recall notice.
Verify the implant size on the label; the recalled model shows size 3 but is actually size 4.
No, the labeling error does not pose an immediate safety risk. The error could lead to improper fitting if not corrected, but it does not cause injury in normal use.
No action is required as the error is not dangerous. However, you should check the label to confirm the size if you have the implant.
The recalled lot numbers are 05144883 and 05144884.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2926-2020 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2926-2020 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.
