Lower riskMedical device recall · FDA · Published January 23, 2018
Implant Direct Interactive Healing Collar Recall: Sterile Labeling Issue
Implant Direct recalls a specific Interactive Healing Collar model due to improper sterilization before labeling as sterile. Affected units may pose infection risks if used.
“Implant Direct Interactive Healing Collar Recall: Sterile Labeling Issue.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72109-implant-direct-interactive-healing-collar-recall-sterile-labeling-issue. Based on FDA recall #Z-0539-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0539-2018%22&limit=1).
Implant Direct Sybron Manufacturing LLC voluntarily recalled 55 units of its INTERACTIVE HEALING COLLAR (Part Number 6530-15) distributed prior to sterilization, according to the FDA on January 23, 2018.
How to tell if you have it
Brand: Implant Direct
Product: INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Lot Number: 104203
The hazard
The InterActive Healing Collar was labeled as sterile but was distributed prior to being sterilized.
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 Medline Convenience Kits Recall (January 7, 2026), Medline Centurion Circumcision Kit Not Sterile (March 16, 2026), and Medline Surgical Packs Recall (January 7, 2026).
How to tell if you have this one
Check for the product name 'Interactive Healing Collar', part number 6530-15, and lot number 104203. The device is a 5.0mmL: 3.0mmD Platform model.
Brand
Implant Direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the product name, part number, and lot number to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Idaho, Iowa, New Jersey, South Carolina, Virginia.
Recall timeline
FDA terminated this recall 7 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-0539-2018 (January 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0539-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.