Implant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws
Implant Direct is recalling 78 Legacy 3 dental implants because some packages contain incorrect cover screws and extenders, which may delay surgery or require new procedures.
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 hazard involves incorrect components leading to surgical delays or additional procedures, which fits the criteria for a moderate severity recall without reported serious injuries.
Plain-English summary
Implant Direct Sybron Manufacturing LLC is recalling 78 units of the Legacy 3 Implant (REF: 855710, Lot # 68209). The recall was initiated after a customer complaint and internal investigation revealed that some implant packages contain the incorrect cover screw and extender.
The affected products are distributed across 23 states, including AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, OH, OR, PA, TX, UT, WA, WI, WV, GA, and MO. The presence of incorrect components could result in a delay in surgery and/or a potential new surgical procedure to place the correct parts. The level of severity varies based on whether a one or two-stage surgery is performed.
Healthcare professionals and patients should contact their provider or the manufacturer for instructions on how to proceed with the affected implants.
The recalled product
- Product
- Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
- Manufacturer
- Implant Direct Sybron Manufacturing LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 78
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 # 68209
Distribution
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