Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
FDA Recall Z-0920-2025 · Posted 2025-01-15
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Recalling FirmSIN SISTEMA DE IMPLANTE NACIONAL S.A
Recall StatusOpen, Classified
Product CodeDZE
Date Initiated2024-09-01
Product Quantity123 (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.
Firm 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].
Root Cause
Process control
Distribution Pattern
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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