Exactech recalls Tibial Alignment Guide (REF 351-10-00 Vantage Fixed Ankle) due to incorrect Global Trade Item Number (GTIN). Affected units have GTIN 10885862525629 instead of 10885862525628.
Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.
Exactech is recalling Tibial Alignment Guides for ankle replacements because the product's GTIN number is incorrect. This error means the device might not be properly identified, but it does not pose a safety risk to patients.
The GTIN (a unique product identifier) is incorrect on the device. This could lead to confusion during medical procedures, but the recall does not indicate any safety hazard to patients.
Patients who received the Tibial Alignment Guide (REF 351-10-00 Vantage Fixed Ankle) for ankle replacements. Surgeons and medical facilities using the product are most at risk of misidentification.
Check if your Tibial Alignment Guide has the GTIN 10885862525629 instead of the correct 10885862525628. The product was sold with Lot Number 098299003.
Verify the GTIN on your Tibial Alignment Guide; it should read 10885862525628, not 10885862525629.
No, the recall is due to an incorrect GTIN number, not a safety hazard. The device does not pose a risk to patients.
Check the GTIN on your device; if it reads 10885862525629, it is affected. However, no action is required beyond verification as there is no safety risk.
Look for the GTIN 10885862525629 on the device instead of the correct 10885862525628. The product was sold with Lot Number 098299003.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2966-2018 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2966-2018 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.
