Lower riskMedical device recall · FDA · Published March 14, 2018
Implant Direct Sybron recall: Incorrect cap label on dental implants
Implant Direct Sybron recalls dental implants with incorrect cap labeling. The cap may show wrong part numbers but the main vial label is correct. Consumers should check their product details.
“Implant Direct Sybron recall: Incorrect cap label on dental implants.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71716-implant-direct-sybron-recall-incorrect-cap-label-on-dental-implants. Based on FDA recall #Z-1917-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1917-2018%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled the ImplantDirect simply InterActive Implant due to an incorrect part number label on the vial cap, according to the FDA. The agency announced the Class II recall on March 14, 2018.
How to tell if you have it
Brand: Implant Direct
Product: ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile
Lot #: 68960
The hazard
The cap on the vial might be labeled with the incorrect part number while the main vial label is correct. The incorrect label on the cap says 4.3mmD Platform 604313U 13mmL.
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 (July 13, 2026), and Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026).
How to tell if you have this one
Check if the cap label says '4.3mmD Platform 604313U 13mmL' while the main vial label shows '5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U'. The product was sold with lot number 68960.
Brand
Implant Direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cap Label
Look for the cap label stating '4.3mmD Platform 604313U 13mmL' while the main vial label shows '5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U'.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Idaho, Illinois, Kentucky, Nebraska, New York, North Carolina, Oklahoma, Oregon, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3 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-1917-2018 (March 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1917-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.