PlainRecalls

Ossur H / F

21 recalls on record · Latest: May 22, 2024

FDA Devices Moderate May 22, 2024

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Devices Moderate May 22, 2024

RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Devices Moderate May 22, 2024

RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Devices Moderate May 22, 2024

RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Devices Moderate Jan 31, 2024

Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

FDA Devices Moderate Jun 21, 2023

Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, RE…

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring tr…

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring tr…

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring …

FDA Devices Moderate Apr 6, 2016

Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative…

FDA Devices Moderate Apr 6, 2016

Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament inju…

FDA Devices Moderate Apr 6, 2016

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 …

FDA Devices Moderate Apr 6, 2016

Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to liga…

FDA Devices Moderate Apr 6, 2016

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

FDA Devices Moderate Apr 6, 2016

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

FDA Devices Moderate Apr 6, 2016

Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black

FDA Devices Moderate Apr 6, 2016

Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and os…

FDA Devices Moderate Apr 6, 2016

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

FDA Devices Moderate Apr 6, 2016

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

FDA Devices Moderate Apr 6, 2016

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

FDA Devices Moderate Apr 1, 2015

The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to con…