The Recall Desk

FDA (Devices) recall action 73380

Ossur H / F recalled 14 products on 2016-04-06

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products
14
Announced
2016-04-06
Critical
0
Units
27,899

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–14 of 14

  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers

    Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.

    Product
    Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Rebound Cartilage Knee Braces and Other Medical Devices

    Ossur Americas is recalling Rebound Cartilage knee braces and other medical devices due to a defect described in the source text.

    Product
    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls NecLoc Extrication Collars and Other Medical Devices

    Ossur Americas is recalling NecLoc Extrication Collars and other medical devices due to a defect described as 'the p'.

    Product
    NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Medical Devices Including Miami J Collars

    Ossur Americas is recalling various medical devices, including Miami J collars and knee shields, due to a manufacturing defect.

    Product
    Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including the Unloader Custom Lite, due to a defect described in the source text.

    Product
    Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Rebound Diabetic Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Diabetic Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Papoose Infant Spine Immobilizers and Other Medical Devices

    Ossur Americas is recalling Papoose Infant Spine Immobilizers and other orthopedic devices due to a defect described as 'the p'.

    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 secure
    Category
    Distribution
    48 states
  • LowFDA (Devices)··2016-04-06

    Ossur Recalls Knee Shields and Medical Devices Due to Packaging Defect

    Ossur Americas is recalling various medical devices, including knee shields and walkers, because the packaging is defective.

    Product
    Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Rebound Air Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Air Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including knee braces and back supports, due to a defect described as 'the p'.

    Product
    Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices due to unspecified product defects.

    Product
    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Distribution
    48 states
  • ModerateFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Distribution
    48 states