The Recall Desk

Manufacturer

Ossur North America Inc

1 recall in our database name Ossur North America Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2013-11-27

Of the 1 recalls from Ossur North America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • SevereFDA (Devices)·Z-0362-2014·2013-11-27

    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.

    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
    Category
    Medical Device
    Distribution
    10 states