Implant Direct Sybron Recalls Legacy 3 Dental Implants Due to Incorrect Packaging
Implant Direct Sybron is recalling 72 Legacy 3 dental implants because some packages contain incorrect implants, which could lead to surgery rescheduling.
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 source text explicitly states the hazard is limited to surgery rescheduling with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Implant Direct Sybron Manufacturing LLC is recalling 72 units of the Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213. The recall is due to some dental implant packages containing incorrect implants.
The affected products were distributed nationwide in the United States in the states of KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, and WA. The products were also distributed in Germany, Italy, Hungary, and Japan. The specific lot number is 83327.
The FDA classifies this as a Class II recall. The presence of incorrect implants in the packages could lead to surgery rescheduling. No injuries or illnesses have been reported.
The recalled product
- Product
- Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
- Manufacturer
- Implant Direct Sybron Manufacturing LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 72
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: 83327
Distribution
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