FDA Medical devices recall ·
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm recall
- Recall number
- Z-0920-2025
- Date
- (initiated September 1, 2024)
- Company / brand
- Sin Sistema De Implante Nacional S.A
Jardim Analia Franco, Sao Paulo, Brazil - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 123 (US 98, OUS 25)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Why was it recalled?
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Distribution
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
States: California Colorado Florida Idaho Illinois Kentucky New Jersey New York Ohio Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0920-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.