Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fixed Offset Adapter Recalled by Ossur North America Inc Due to Ossur inititated a voluntary recall of the A-642100...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ossur North America Inc directly.
Affected Products
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: 14,5mm (0.57inch).
Quantity: 66 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 10 states: AL, CA, GA, ID, NJ, NY, NC, TX, VA, WI
About Ossur North America Inc
Ossur North America Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report