Recall Z-0920-2025— SIN SISTEMA DE IMPLANTE NACIONAL S.A

Name: FDA recall Z-0920-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-01

Class II · Ongoing

Class II FDA medical device recall by SIN SISTEMA DE IMPLANTE NACIONAL S.A, initiated 2024-09-01. It names one FDA 510(k) clearance: K222231. Product: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N. Reason: 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..

Recalling firm: SIN SISTEMA DE IMPLANTE NACIONAL S.A
Classification: Class II
Status: Ongoing
Initiated: 2024-09-01
Firm location: Sao Paulo, Brazil

510(k) clearances named in this recall

1 on FDA's record

K222231 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.·cleared 2022-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.