Ossur H / F: 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

Agency Publication Date: March 31, 2016

Affected Products

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.

Item No: B-250110000

Product: Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.

Item No: B-250150201 B-250150202 B-250150203 B-250150204 B-250150205 B-250150206

Product: NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.

Item No.: NL-200EL NL-250E NL-300E NL-400E NL-500E NL-P1 NL-P2 NL-P3

Product: Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.

Item No: MJ-200B MJ-200L MJ-200LFRT MJ-200S MJ-200SFRT MJ-250 MJ-250FRT MJ-2530 MJ-300 MJ-300FRT MJ-400 MJ-400FRT MJ-500 MJ-500FRT MJ-P2 MJ-P3 MJR-200L MJR-200S MJR-250 MJR-2530 MJR-300 MJR-400 MJR-500 MJR-P2 MJR-P3

Product: Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.

Item No: B-254510002 B-254510003 B-254510004 B-254510005 B-254520002 B-254520003 B-254520004 B-254520005 B-254610002 B-254610003 B-254610004 B-254610005 B-254620002 B-254620003 B-254620004 B-254620005 B-254710002 B-254710003 B-254710004 B-254710005 B-254720002 B-254720003 B-254720004 B-254720005 B-254810002 B-254810003 B-254810004 B-254810005 B-254820002 B-254820003 B-254820004 B-254820005

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.

Item No: B-254500001 B-254600001 B-254700001 B-254800001

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.

Item No: B-242900001 B-242900001E B-242900001SE B-242900002 B-242900002E B-242900002SE B-242900003 B-242900003E B-242900003SE B-242900004 B-242900004E B-242900004SE B-242900005 B-242900005E B-242900005SE B-242900061 B-242900061E B-242900061SE B-242900062 B-242900062E B-242900062SE B-242900063 B-242900063E B-242900063SE B-242900064 B-242900064E B-242900064SE B-242900065 B-242900065E B-242900065SE

Product: Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.

Item No: B-242500002 B-242500003 B-242500004 B-242500005

Product: Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black

Item No: 10912 10913

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.

Item No: B-102500010 B-102500020 B-102600010 B-102600020

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.

Item No: B-107500020 B-107600020

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

Item No: B-122500020 B-122600020

Product: Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

Item No: B-108500010 B-108500020 B-108600010 B-108600020 B-123500020 B-123600020

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.

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 All lot numbers from MX140101 to MX150930

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73380

Status: Resolved

Manufacturer: Ossur H / F

Manufactured In: Iceland

Units Affected: 14 products (7; 456; 2010; 15,825; 1030; 24; 7623; 34; 2; 15; 9; 456; 7; 401)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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