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All Recalls

Every Ossur H / F Recall

Sorted by most recent. Click any recall for full details.

21 recalls
High RiskFDA
Ossur H / F
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·0 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·1 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·107 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·143 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Medical Devices·544 affected·Dec 26, 2023
High RiskFDA
Ossur H / F
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adap...
Medical Devices·4,190 affected·May 12, 2023
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders ...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders ...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorder...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, po...
Medical Devices·7,623 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to l...
Medical Devices·9 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO fro...
Medical Devices·401 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability...
Medical Devices·24 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligame...
Medical Devices·1,030 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
Medical Devices·456 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
Medical Devices·2 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament inj...
Medical Devices·15 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injur...
Medical Devices·7 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Medical Devices·15,825 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobiliza...
Medical Devices·2,010 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelli...
Medical Implants·4,715 affected·Feb 26, 2015