Reported Feb 28, 2018 · Terminated
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Allen Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allen Medical Systems · 100 Discovery Way · Acton, MA · 01720-4481
Is this the product you have?
- Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Lot codes and dates
- Serial Number
533552536025536451539585539795535272536026536452539586542764535273536027536453539587544938535274536028536454539588544939535386536029536455539589544940535387536030536456539794546200
- Serial Number
- Amount recalled
- 161 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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