The National Administration of Medicines, Food and Medical Technology (ANMAT) has warned the population about a screw used in trauma surgeries because it is counterfeit, so its use poses a health risk to the patient it is implanted in.
It is a screw used in trauma surgeries that was detected during a market control inspection at an orthopedics located in the city of San Miguel de Tucumán. This screw is produced by the firm Stryker Corporation, which is registered with ANMAT under PM 594-139.
They must be identified with the manufacturer or importer's data, no. After the inspection, the collected sample was presented to the technical responsible of said company, who affirmed that it was a counterfeit product.
ANMAT authorities made the characteristics of the product known for warning:
STRYKER 10 mm X 28 mm - BIOABSORBABLE - ACL INTERFERENCE SCREW - REF 234-010-067 - LOT 90905.
Among the differences found between an original and a fake product, it was found:
The original unit has an expiration date while the counterfeit unit does not have this data. The Stryker firm has never used a 3M brand pouch for this product. The original product is sterilized by Gamma Radiation, while the counterfeit unit would have been sterilized by steam or formaldehyde. The original screw is opaque gray in color, while the one in the counterfeit unit, as observed through the transparent pouch, is colorless.
According to what Agencia Noticias Argentinas learned, being a counterfeit product, the origin, composition, safety and suitability of the mentioned product are unknown, so its use poses a risk to the health of the patient to whom it is implanted.
In this scenario, it is recommended:
If you have the mentioned product, do not use it and contact ANMAT. Always acquire registered medical products.
