FDA (Devices) recall action 71058
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Advanced Back Technologies is recalling 36 Extentrac Elite powered decompression tables because the product brochure incorrectly states a 350-lb weight limit, while the device is only approved for patients up to 300 lbs.
Advanced Back Technologies is recalling 18 Extentrac Elite User Manuals because they incorrectly state the device is for patients up to 350 lbs, while the device is only approved for up to 300 lbs.