Ossur Americas, Inc.

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
1
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1821-2022Class IIOSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L August 29, 2022
Z-1330-2022Class IIOSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.May 30, 2022
Z-0380-2022Class IIMiami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions forNovember 9, 2021
Z-1896-2021Class IIOSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervJune 1, 2021
Z-0997-2019Class IIOssur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK;June 21, 2018
Z-1001-2019Class IIOssur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM;June 21, 2018
Z-1004-2019Class IIOssur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGELJune 21, 2018
Z-0999-2019Class IIOssur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OJune 21, 2018
Z-1003-2019Class IIOssur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ RJune 21, 2018
Z-1000-2019Class IIOssur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CJune 21, 2018
Z-0998-2019Class IIOssur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl June 21, 2018
Z-1002-2019Class IIOssur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMJune 21, 2018
Z-1097-2014Class IIThe SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputeesOctober 15, 2012
Z-0936-2014Class IIThe Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputeesFebruary 12, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K130174DVTCARE CA5May 2, 2013