Lower riskMedical device recall · FDA · Published August 9, 2019
Implant Direct Legacy 2 Implant Recall: Wrong Healing Collar Packaged
Implant Direct recalls Legacy 2 dental implants due to incorrect Healing Collar packaging. Affected units may have safety risks from improper implant delivery.
“Implant Direct Legacy 2 Implant Recall: Wrong Healing Collar Packaged.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67236-implant-direct-legacy-2-implant-recall-wrong-healing-collar-packaged. Based on FDA recall #Z-0364-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0364-2020%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled 23 Legacy 2 dental implants on Aug. 9, 2019, after the FDA announced a QA inspection confirmed a Healing Collar was packaged instead of the ordered Implant. The recall involved products distributed in the U.S. and Japan.
How to tell if you have it
Brand: Implant Direct
Product: Legacy 2 Implant
REF: 833708
Lot #: 135128
Exp: 3/12/20
Size: 3.7mmD x 8mmL, 3.5mmD Platform
Surface: HA
The hazard
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Context
GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has 20 other recalls on record since June 26, 2017. Other recent recalls of similar products include Sybron Drill Stop Kit Recall (May 1, 2025), Sybron Legacy Smartbase Recalls (May 2, 2023), and ImplantDirect Legacy 2 dental implants recalled for incorrect size labeling (Sept. 23, 2021). Other recent recalls of similar products include Straumann GM Helix Dental Implant Recall (July 13, 2026), Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026), and Straumann Dental Implant Abutments Recall (March 27, 2026).
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.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: IN, VA, MD, TX, WA OUS: Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.
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.