SIN SISTEMA DE IMPLANTE NACIONAL S.A is recalling 123 units of its Epikut S Plus CM 16-Degrees dental implants because the diameter listed on the outer box is incorrect. While the box says the implant is 4.5 mm wide, the device inside is actually 4.0 mm wide. If a dentist prepares the patient's bone based on the larger box measurement, the actual implant will be too small to fit securely. No injuries have been reported, but this error could lead to loose implants and the need for additional surgery.
If a surgeon drills a hole in the bone for a 4.5 mm implant as indicated on the box, the actual 4.0 mm implant will fit loosely and fail to stabilize. This mismatch can cause the implant to fail and may require a second surgical procedure to correct the issue.
Internal label correctly identifies the 4.0 mm diameter; box incorrectly labels it as 4.5 mm.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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