Implant Direct Interactive Healing Collar Recalled for Sterility Labeling Error
Implant Direct is recalling 55 Interactive Healing Collars labeled as sterile but distributed before sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding sterility, which fits the criteria for moderate severity as it is a minor labeling error without reported injuries.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 55 units of the Implant Direct Interactive Healing Collar, Part Number 6530-15, 5.0mmL: 3.0mmD Platform. The affected units are from Lot Number 104203. The recall is due to a labeling error where the products were labeled as sterile but were distributed prior to being sterilized.
The affected products were distributed to locations in Colorado, South Carolina, Iowa, New Jersey, Florida, California, Virginia, Idaho, and the Netherlands. The U.S. Food and Drug Administration has classified this recall as Class II.
Healthcare providers and patients should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 55
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 104203
Distribution
Related recalls
Same manufacturer · Implant Direct Sybron Manufacturing, LLC
See all →- ModerateSterilizable Drill Stop Kits were shipped containing incorrect components
FDA (Devices) · 2025-08-06
- HighDental Implant Abutments Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2023-07-05
- HighDental implant recalled due to size mismatch with labeling
FDA (Devices) · 2021-11-10
- HighDental implants recalled for size mismatch with package labeling
FDA (Devices) · 2021-11-10
- ModerateImplant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws
FDA (Devices) · 2020-02-19
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateImplant Direct Dental Implants Recalled for Potential Packaging Error
FDA (Devices) · 2019-11-20
- ModerateImplant Direct Recalls Dental Implants Due to Packaging Error
FDA (Devices) · 2019-11-20
- ModerateImplant Direct Recalls Swish Duo-Grip Healing Collars Due to Wrong Component
FDA (Devices) · 2017-10-11
- LowImplant Direct Legacy 4 Implant Recalled for Mislabeling
FDA (Devices) · 2018-05-30
- ModerateImplant Direct Dental Implants Recalled for Incorrect Cap Labeling
FDA (Devices) · 2018-05-30
- ModerateImplant Direct Sybron Recalls Mislabeled Dental Implant Vials
FDA (Devices) · 2019-10-09