Implant Direct Recalls Legacy Full-Contour Abutments for Specification Deviations
Implant Direct Sybron Manufacturing is recalling 151 Legacy Full-Contour Abutments because they may be out of specification.
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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 151 units of the Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD. The recall was initiated because the products may be out of Implant Direct specification.
The affected products were distributed worldwide, including nationwide distribution in the United States and to the European Union (HU, GB, DE, DK, IT, HR, FR) and Japan. The recall is associated with codes 89103, 83493, and 78986.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 151
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)
- 89103
- 83493
- 78986
Distribution
Distributed nationwide across the United States.
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