Micro-Tech Usa Elastic Traction Device, 11mm Lower recall — FDA Z-0470-2021
FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
Overview of recall records associated with Micro-Tech Usa, including dates, categories and classifications where available.
Classification mix: Class II: 1.
FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
This page summarizes recall records in which the official source identifies Micro-Tech Usa as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.