Implant Direct Legacy 4 Implant Recalled for Mislabeling
Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a minor labeling error on the vial cap where the main label was correct, fitting the rubric for cosmetic defects or documentation issues.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 18 units of ImplantDirect Legacy 4 Implants, 5.7mmD x 5.7mmD Platform, Part 885708. The recall is due to a labeling error on the vial cap.
The vial cap was mislabeled with the incorrect part number 855708, although the product description on the cap was correct. The main vial label was correctly labeled. The affected lot is #71729.
Distribution was made to Florida, Georgia, Maryland, Michigan, North Carolina, New York, Oregon, Texas, Utah, and Virginia. There was no foreign, military, or government distribution. Consumers and healthcare providers should check their inventory for this specific part number and lot.
The recalled product
- Product
- ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 18
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 #71729
Distribution
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