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Allen Medical Systems recalls Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Recalled February 28, 2018 · FDA recall Z-0642-2018 · Allen Medical Systems
Hazard
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. · FDA Class II
Units
161 units total
Sold at
Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
Description
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Product
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Manufacturer(s)
Allen Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →