Lower riskMedical device recall · FDA · Published August 8, 2018
Implant Direct Legacy 3 Implant: Mislabeling Risk in Vial Caps
Implant Direct recalls Legacy 3 implants with mislabeled vial caps (part number 835216) that could lead to incorrect usage. Affected units have a specific model and lot number.
“Implant Direct Legacy 3 Implant: Mislabeling Risk in Vial Caps.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70121-implant-direct-legacy-3-implant-mislabeling-risk-in-vial-caps. Based on FDA recall #Z-0018-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0018-2020%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled one lot of ImplantDirect Legacy 3 Implants on Aug. 8, 2018, the FDA said. The vial caps were mislabeled with an incorrect part number. The recall was classified as Class II.
Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
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 EMPOWR 3D KNEE Implants Have Incorrect Labeling (Jan. 15, 2026), Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk (July 13, 2026), and Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (June 8, 2026).
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.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Hawaii, Idaho, Kansas, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Utah.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3FDA terminated the recall
4Published in FDA’s Enforcement Report
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-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.