Lower riskMedical device recall · FDA · Published October 10, 2017
ImplantDirect Legacy 3 Implant Recall: Risk of Sterilization Compromise
ImplantDirect Legacy 3 Implant (13mm L, REF 864713) recalled due to potential sterilization compromise from improper cap sealing. Affected units sold with lot number 79607.
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
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Contact the company
📍Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
“ImplantDirect Legacy 3 Implant Recall: Risk of Sterilization Compromise.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72879-implantdirect-legacy-3-implant-recall-risk-of-sterilization-compromise. Based on FDA recall #Z-0185-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0185-2018%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled the ImplantDirect Legacy(TM) 3 Implant, 13MM L (REF 864713), lot 79607, due to sterility compromise risks. The Food and Drug Administration announced the voluntary Class II recall on October 10, 2017.
How to tell if you have it
ImplantDirect Legacy(TM) 3 Implant, 13MM L
REF 864713
Lot Number: 79607
The hazard
The FDA found that the outer vial was out of round and undersized, preventing components from sliding freely. This may cause the cap to not screw on properly, compromising sterilization. One complaint was reported regarding this issue.
Context
GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has issued 20 other recalls since June 26, 2017. Recent brand recalls include the May 1, 2025 Sybron Drill Stop Kit for incorrect components and the May 2, 2023 Sybron Legacy Smartbase for unapproved non-engaging abutments. Other recent recalls of similar products include the June 23, 2026 Arrowhead Implant (potential infection risk from sterility issues), the July 13, 2026 Straumann GM Helix Dental Implant (packaging mismatch risk), and the July 31, 2026 Bayer Stellant FLEX Syringe Kit (sterilization issue risk).
How to tell if you have this one
Check for the product name 'Legacy 3 Implant', size 13mm L, and reference number 864713. Affected units were sold with lot number 79607.
Brand
ImplantDirect
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, size, reference number, and lot number to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0185-2018 (October 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0185-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.