Implant Direct Legacy 2 Dental Implant Recall: Wrong Size Labeling
Implant Direct recalls Legacy 2 dental implants that have incorrect size labeling compared to actual product. This mismatch could lead to improper fit during dental procedures.
Lower-risk recall
Packaged dental implant contains a different size then the size declared on the labeling.
Contact the company
What happened, in plain English
Implant Direct is recalling Legacy 2 dental implants that have a different size than what's labeled. This mismatch could cause improper fitting during dental procedures, potentially leading to complications. Read more at govinfonow.com/recall/61756-implant-direct-legacy-2-dental-implant-recall-wrong-size-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/61756-implant-direct-legacy-2-dental-implant-recall-wrong-size-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0198-2022
Cite this page
“Implant Direct Legacy 2 Dental Implant Recall: Wrong Size Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61756-implant-direct-legacy-2-dental-implant-recall-wrong-size-labeling. Based on FDA recall #Z-0198-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0198-2022%22&limit=1).
Why it’s dangerous
The dental implant packaging lists a different size than the actual implant. This mismatch could lead to improper fitting during dental procedures, potentially causing complications like poor integration with the jawbone or incorrect placement.
Who’s affected
Dental patients who received Legacy 2 implants with the specified dimensions (4.7mmD x 13mmL, 4.5mmD Platform) from the recall batch. Dentists and dental clinics using these implants are most at risk.
How to tell if you have this one
Check for the Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform model with lot number 166300 or UDI: 10841307101796. This recall applies to implants sold under the ImplantDirect brand.
- Brand
Implant Direct- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0197-2022 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,; lot # 166297 / UDI: 10841307101789 | 61 implants |
| Z-0198-2022 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,; lot # 166300 / UDI: 10841307101796 | 83 implants |
What to do — step by step
Check Product Details
Verify the implant's dimensions and lot number against the recall list to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 24 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Hawaii, Illinois, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0198-2022 (September 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0198-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.