The Recall Desk
SevereFDA (Devices)·Z-0362-2014·Announced 2013-11-27

Ossur Fixed Offset Adapter Recalled for Fatigue Cracks and Separation Risk

Ossur North America Inc is voluntarily recalling 66 units of the A-642100 Fixed Offset Adapter because the component can develop fatigue cracks and separate completely during normal use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device (prosthetic component) that can lead to complete separation, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury risk, warranting a Severe rating.

Plain-English summary

Ossur North America Inc has initiated a voluntary recall of the A-642100 Fixed Offset Adapter. This fixed modular component is made of high-strength alloy and is intended to offset the tube 14.5 mm (0.57 inch) from the center line of the pyramid in prosthetic applications. It is fully compatible with all standard 30mm prosthetic pylons.

The recall is being conducted because the adapter can develop fatigue cracks in normal use over an extended period of time, which can ultimately lead to complete separation of the component. The recall involves 66 units with Item Number A-642100 and all serial numbers.

The affected products were distributed in the United States, including the states of Alabama, Texas, New York, California, Virginia, Georgia, Wisconsin, North Carolina, Idaho, and New Jersey. Users of these prosthetic components should contact Ossur North America Inc for further instructions on how to proceed with the recall.

The recalled product

Product
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 t
Manufacturer
Ossur North America Inc
Category
Medical Device — Prosthetic Component
Hazard
Affected units
66

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Item Number: A-642100 All Serial Numbers.

Distribution

Distributed in 10 states:

Related recalls

Same hazard · structural failure

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