The National Administration of Medicines and Medical Technology (ANMAT) has banned the use and marketing of counterfeit titanium anchors, as they lack safety and traceability data. This measure was announced through resolution 9577/2024 published in the Official Bulletin.
It all started when the institution conducted an inspection at the company "Ortopedia Insumos San Juan" of Milagrosa Medic SRL, located at Patricias Sanjuaninas 397 in the city of San Juan. During the inspection, it was discovered that several products did not have expiry lots or the necessary material for proper packaging.
Following this finding, samples of the product were sent to the ANMAT offices in the city of Buenos Aires. There, it was determined that the 2 mm anchor for simple suturing, supposedly packaged by Biotrom S.A., was counterfeit, as confirmed by a representative of Biotrom SA after testing the product.
ANMAT indicated that the counterfeit product did not comply with regulations or with the backing of the company. The inspections also revealed discrepancies in the packaging and sterilization methods of the product, which poses a risk to public health.
In light of this situation, the administration strengthens quality and safety controls in medical supplies and warns distributors and consumers about the risks of purchasing unregulated products. The regulation states that the product is in violation to protect potential buyers and users of it.
