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Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM… recallZ-0920-2025 · Sin Sistema De Implante Nacional S.A · initiated Sep 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sin Sistema De Implante Nacional S.A or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number
Z-0920-2025
Status
Open, Classified
Initiated by the company
Sep 1, 2024
Posted by the FDA
Jan 15, 2025
Recalling firm
Sin Sistema De Implante Nacional S.A
Quantity
123 (US 98, OUS 25)
Product code
DZE
FDA submissions
K222231
Distribution
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

32 devices cleared under K222231 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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