Implant Direct Legacy 2 Implant Recall: Wrong Healing Collar Packaged

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Implant Direct is recalling Legacy 2 dental implants because a Healing Collar was mistakenly packaged instead of the ordered implant. This could lead to improper implant placement and potential complications during dental procedures.

Why it’s dangerous

The recall occurs because a Healing Collar (part number 8735-15) was shipped instead of the intended implant. This mismatch could cause improper implant placement during dental procedures, potentially leading to complications.

Who’s affected

Dental patients who received Legacy 2 implants with the specific model and lot number (135128) from Implant Direct. Patients with implants are most at risk.

How to tell if you have this one

Check for the Legacy 2 Implant model with dimensions 3.7mmD x 8mmL, 3.5mmD Platform, and lot number 135128. The product was sold with an expiration date of 3/12/2020.

Brand
Implant Direct
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Implant Details
Review the implant's model, dimensions, and lot number to confirm if it matches the recalled specifications.

✎ GovInfoNow

Questions people ask

Why is this implant being recalled?

A QA inspection confirmed that a Healing Collar (part number 8735-15) was packaged instead of the ordered implant.

What should I do if I have this implant?

The recall record does not specify any action steps for affected users.

Is there a risk of serious injury from this implant?

The recall does not mention a risk of serious injury; it focuses on improper implant delivery.

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-0364-2020 — Implant Direct Implant Direct

Hello,

I own a Implant Direct that is covered by recall Z-0364-2020 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-0364-2020 (August 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0364-2020 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.

Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in

Lower-risk recall