Allen Medical Systems recalls Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Recall date
- October 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0642-2018
- FDA classification
- Class II
- Brand / firm
- Allen Medical Systems
- Sold / distributed
- 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.
Why it was recalled
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
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