Advanced Back Technologies Extentrac Elite User Manual DCN: 14-001 recall — FDA Z-1718-2015
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Overview of recall records associated with Advanced Back Technologies, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
This page summarizes recall records in which the official source identifies Advanced Back Technologies, Inc. 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.