Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Summary
The FDA issued a Class II for Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N by SIN SISTEMA DE IMPLANTE NACIONAL S.A. 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 den.
Details
Source
Device Recall
External ID
Z-0920-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Lot/Code Info: UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Quantity Affected: 123 (US 98, OUS 25)
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.
Distribution
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-01
Company
Sao Paulo
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SIN SISTEMA DE IMPLANTE NACIONAL S.A) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SIN SISTEMA DE IMPLANTE NACIONAL S.A have FDA actions?
This is the only FDA action we have on record for SIN SISTEMA DE IMPLANTE NACIONAL S.A in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0920-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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