Implant Direct Dental Implants Recalled for Incorrect Cap Labeling
Implant Direct Sybron Manufacturing is recalling 298 dental implants because the vial cap may display an incorrect part number, though the main label is correct.
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, but the hazard is limited to a labeling error on the cap where the main label is correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 298 units of the ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U. The recall is due to a labeling error where the cap on the vial may be labeled with the incorrect part number (4.3mmD Platform 604313U 13mmL), while the main vial label remains correct.
The affected products are dental implants intended for use in partially and fully edentulous upper and lower jaws. The recall covers Lot #68960. Distribution was worldwide, including the United States (AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI) and foreign countries including Canada, Japan, the United Kingdom, France, Switzerland, the Netherlands, and Germany.
Consumers and healthcare providers should verify the main vial label to ensure the correct part number is used for the implant procedure.
The recalled product
- Product
- ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and…
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 298
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 #68960
Distribution
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