Implant Direct Dental Implants Recalled for Potential Packaging Error
Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.
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 packaging error where an incorrect component could be present. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a potential packaging defect rather than a confirmed high-risk pathogen or structural failure.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 53 units of the Implant Direct simply InterActive Dental Implant (REF654311U). The recall was initiated after an internal quality assurance inspection revealed that an incorrect healing collar could have been packaged in the implant assembly kit.
The affected products are sterile dental implants with a 4.3mm diameter and 11.5mm length. The recall covers specific lot numbers 120197 (expiration 07/16/2023) and 120198 (expiration 07/19/2023). These products were distributed in the United States to the states of CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, and CO.
Healthcare professionals and patients who have received these specific implants should contact their provider or the manufacturer for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 53
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 (3)
- Lot numbers 120197
- Exp. 07/16/2023 and 120198
- Exp. 07/19/2023
Distribution
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