Recall Z-1298-2016— Ossur H / F

Class II FDA medical device recall by Ossur H / F, initiated 2016-02-24, terminated 2016-08-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.. Reason: Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p.

Recalling firm

Ossur H / F

Classification

Class II

Status

Terminated

Initiated

2016-02-24

Terminated

2016-08-15

Firm location

Reykjavik, N/A, Iceland

Data sourced from openFDA. This site is unofficial and independent of the FDA.