Ossur H / F

FDA Regulatory Profile

Summary

Total Recalls
29
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0006-2025Class IIMiami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101August 20, 2024
Z-1790-2024Class IIRKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic componentMarch 25, 2024
Z-1787-2024Class IIRKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic componentMarch 25, 2024
Z-1789-2024Class IIRKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentMarch 25, 2024
Z-1788-2024Class IIRKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentMarch 25, 2024
Z-0788-2024Class IIPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002December 26, 2023
Z-1906-2023Class IIIcelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REFMay 12, 2023
Z-1510-2016Class IIOssur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo systeMarch 14, 2016
Z-1511-2016Class IIOssur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo sMarch 14, 2016
Z-1515-2016Class IIOssur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo sysMarch 14, 2016
Z-1512-2016Class IIOssur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo sMarch 14, 2016
Z-1514-2016Class IIOssur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo syMarch 14, 2016
Z-1513-2016Class IIOssur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo systeMarch 14, 2016
Z-1286-2016Class IIKnee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort undeFebruary 24, 2016
Z-1294-2016Class IIUnloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support forFebruary 24, 2016
Z-1285-2016Class IIKnee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the kFebruary 24, 2016
Z-1297-2016Class IIExtreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for kFebruary 24, 2016
Z-1296-2016Class IIUnloader Custom Product Usage: Unloader Custom is an external knee braces to provide support forFebruary 24, 2016
Z-1289-2016Class IIRebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides suppoFebruary 24, 2016
Z-1298-2016Class IIPapoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacFebruary 24, 2016