Reported Nov 27, 2013 · Terminated
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch)…
Ossur North America Inc.
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: Ossur North America Inc · 27051 Towne Centre Dr · Foothill Ranch, CA · 92610-2804
Is this the product you have?
- Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3)
- Offset
145mm (0.57inch)
- Lot codes and dates
- Item NumberA-642100 All Serial Numbers
- Amount recalled
- 66 units
Where it was sold
Why it was recalled
Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
This product could cause temporary or reversible health problems — stop using it.
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