Implant Direct RePlant Dental Implants Recalled for Incorrect Packaging
Implant Direct Sybron Manufacturing is recalling 158 dental implants because the incorrect device was packaged in the vial.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 158 units of the ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U. The recall was initiated because the incorrect device was packaged in the vial.
The affected devices are identified by Lot 108191 and UDI (01)10841307108313(17)230118(10)108191. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. The devices were distributed to distributors in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Maryland, New Mexico, Nevada, New York, Pennsylvania, and Texas. There was no government or military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and the UAE.
The FDA has classified this recall as Class II. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 158
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 (2)
- Lot 108191
- UDI (01)10841307108313(17)230118(10)108191
Distribution
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