Implant Direct Sybron Recalls Mislabeled Dental Implant Vials
Implant Direct Sybron Manufacturing is recalling 22 vials of dental implants due to incorrect part numbers on the vial caps.
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 identifies the issue as a labeling error (incorrect part number) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 22 vials of ImplantDirect Legacy 3 Implants. The recall is due to a labeling error where two units in distribution were found to be mislabeled on the vial cap with the incorrect part number 835216, instead of the correct reference 855216.
The affected product is the ImplantDirect Legacy 3 Implant, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, sterile. The lot number is 110350. The product was distributed worldwide, including the United States (specifically CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT), Canada, and the United Arab Emirates.
Consumers and healthcare providers should stop using the affected implants and contact the manufacturer for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.…
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 22
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 110350
Distribution
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