ImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number
Implant Direct Sybron Manufacturing is recalling 124 units of ImplantDirect dental implants because the main vial label lists an incorrect part number, although the cap label is correct.
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 labeling error where the main vial label lists an incorrect part number, but the cap label is correct. This is a documentation/packaging issue with no reported injuries or functional defects.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 124 units of ImplantDirect dental implants. These implants are intended for use in partially and fully edentulous upper and lower jaws to support single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
The recall was initiated because the main vial label lists the incorrect part number, while the cap label is correct. The affected units are identified by Lot #87837.
Distribution was made to Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, North Carolina, New Jersey, Nevada, New York, Pennsylvania, Texas, Utah, Virginia, and Washington. There was no government or military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
The recalled product
- Product
- ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 124
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 #87837
Distribution
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