Overview
- Inspectors found the suspect implant during a market-control visit to an orthopedics retailer in San Miguel de Tucumán.
- The product is labeled as STRYKER 10 mm x 28 mm – BIOABSORBABLE – ACL INTERFERENCE SCREW – REF 234-010-067 – LOT 90905.
- Stryker’s technical representative confirmed the item was not manufactured or distributed by the company.
- ANMAT noted red flags including the absence of an expiration date, use of a 3M pouch not employed by Stryker, sterilization inconsistent with gamma radiation, and a color mismatch.
- Authorities advise against using the item, ask holders to contact the agency (including via [email protected]), and recommend purchasing only registered devices with traceable documentation.