Exactech Tibial Alignment Guide: Incorrect GTIN causes recall
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.
Lower-risk recall
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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/70607-exactech-tibial-alignment-guide-incorrect-gtin-causes-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/70607-exactech-tibial-alignment-guide-incorrect-gtin-causes-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2966-2018
Cite this page
“Exactech Tibial Alignment Guide: Incorrect GTIN causes recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70607-exactech-tibial-alignment-guide-incorrect-gtin-causes-recall. Based on FDA recall #Z-2966-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2966-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check if your Tibial Alignment Guide has the GTIN 10885862525629 instead of the correct 10885862525628. The product was sold with Lot Number 098299003.
- Brand
Exactech- Category
Medical device
What to do — step by step
Check GTIN Number
Verify the GTIN on your Tibial Alignment Guide; it should read 10885862525628, not 10885862525629.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, New York, Ohio, Oklahoma, South Carolina, Texas.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-2966-2018 (July 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2966-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.