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.
What this means for you
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
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