Ossur North America Inc: Medical Device Recall in 2013 - (Recall #: Z-0362-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: October 24, 2013

Date Posted: November 27, 2013

Recall Number: Z-0362-2014

Event ID: 66609

Reason for Recall:

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.

Status: Terminated

Product Quantity: 66 units

Code Information:

Item Number: A-642100 All Serial Numbers.

Distribution Pattern:

US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.

Voluntary or Mandated:

Voluntary: Firm initiated