Z-0920-2025Class II

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

Name: Z-0920-2025 Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Creator: Sin Sistema De Implante Nacional S.a
Published: 2024-09-01
License: https://open.fda.gov/license/

S.I.N. Implant System Ltda / initiated 2024-09-01 / Open, Classified / root cause: manufacturing process

FDA source

SIN SISTEMA DE IMPLANTE NACIONAL S.A began a recall of Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N on 2024-09-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0920-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-01
Posted: 2025-01-15
Recalling firm: S.I.N. Implant System Ltda
Product: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 9/1/2024, "URGENT: MEDICAL DEVICE RECALL" notices were emailed to customers and distributors who were told the following: The product should not be used. It does not pose a handling risk and should be separated and discarded. Complete and return the Medical Device Recall Return Response Acknowledgement and Receipt Form via email to: [email protected]. Customer with questions may contact the company via telephone at 0800-770-8290 between the hours of 9 and 19 (Brasilia time) or email the firm at [email protected].
Quantity in commerce: 123 (US 98, OUS 25)
Distribution: US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Product codes and lots: UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15

Product code DZE

K222231Class IIS.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. / cleared 2022-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)