Dental implant packaging incorrectly labeled; internal dimension mismatch may cause loosening
Box label states diameter 4,5 X 18,0 mm but actual implant is 4,0 X 18,0 mm. If dentist drills to box specifications, the smaller implant will not fit and may require revision surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with a documented labeling defect that creates a risk of implant failure and patient harm. However, no injuries or illnesses have been reported. The hazard is real and direct but not yet manifested, fitting the High severity criterion.
Plain-English summary
Implant Epikut S Plus CM 16-Degrees dental implants are being recalled due to a packaging labeling discrepancy. The outer box incorrectly lists the implant diameter as 4,5 X 18,0 mm, while the internal label correctly states 4,0 X 18,0 mm.
If a dentist follows the incorrect box dimensions and drills the jaw bone to a 4,5 X 18,0 mm diameter, the actual 4,0 X 18,0 mm implant will not fit properly in the prepared site. The implant could become loose and necessitate additional surgery for revision or replacement.
The recall affects 123 implants distributed in the United States (Kentucky, Colorado, California, New York, Idaho, New Jersey, Florida, Texas, Illinois, and Ohio) and Brazil. The affected lot is X010469757 with an expiration date of January 2028. Dentists and healthcare facilities should verify their inventory and consult the FDA if they have questions about affected units.
The recalled product
- Product
- Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
- Manufacturer
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Category
- Medical Device — Dental implant
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 (3)
- UDI-DI: 07899995273437
- Lot: X010469757
- Expiration: 2028/01
Distribution
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