Implant Direct Legacy 3 Implant: Mislabeling Risk in Vial Caps

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Contact the company & request your remedy

Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr, N/A · Westlake Village, CA 91362-3171

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Implant Direct is recalling Legacy 3 implants that were mislabeled on the vial cap with the wrong part number. This could cause incorrect usage if the wrong implant is used in dental procedures.

Why it’s dangerous

The vial cap has the incorrect part number (835216) instead of the correct one (855216). This mislabeling could lead to using the wrong implant type during dental procedures, potentially causing incorrect fit or function.

Who’s affected

Dental professionals using Implant Direct Legacy 3 implants with lot number 110350 are affected. Patients receiving these implants may be at risk if the mislabeled part is used.

How to tell if you have this one

Check the vial cap for part number 835216 instead of 855216. Affected units have lot number 110350 and were sold by Implant Direct Sybron Manufacturing LLC.

Brand
Implant Direct
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Vial Cap Label
Look for part number 835216 on the vial cap instead of the correct 855216.

✎ GovInfoNow

Questions people ask

What part number should I look for on the vial cap?

The correct part number is 855216. Affected units have 835216 on the vial cap.

What is the lot number for affected units?

Lot number 110350.

Is there a fix for this issue?

The recall does not provide a remedy; users should check the vial cap label.

Take action

Contact Implant Direct

We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0018-2020 — Implant Direct Implant Direct

Hello,

I own a Implant Direct that is covered by recall Z-0018-2020 from Implant Direct.

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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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-0018-2020 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0018-2020 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.

Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The

Lower-risk recall