Implant Direct Legacy Dental Implants Recalled for Packaging Defect
Implant Direct Sybron Manufacturing is recalling 75 units of Legacy 3 Dental Implants because a packaging defect may compromise sterilization.
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. The hazard involves a packaging defect that may compromise sterilization, representing a potential risk of infection, but no illnesses or injuries have been reported in the source text.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 75 units of ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713. The affected units are identified by Lot Number 79607. These two-piece dental implants are intended for use in partially and fully edentulous upper and lower jaws to support restorations and abutments.
The recall was initiated after one reported complaint revealed that the outer vial was out of round and undersized. This defect may prevent the inner vial and components from sliding freely out of the packaging. Consequently, the cap may not screw on properly, which could compromise the sterilization of the implant components.
The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Japan. Consumers and healthcare providers should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit…
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 75
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 Number: 79607
Distribution
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