Ossur Americas, Inc.
FDA Regulatory Profile
Ossur Americas, Inc. appears in FDA public data with 14 recalls, 1 510(k) clearance, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1821-2022, Class II) was initiated on August 29, 2022. Its most recent 510(k) clearance was granted on May 2, 2013.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 1
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1821-2022 | Class II | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L | August 29, 2022 |
| Z-1330-2022 | Class II | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. | May 30, 2022 |
| Z-0380-2022 | Class II | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for | November 9, 2021 |
| Z-1896-2021 | Class II | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cerv | June 1, 2021 |
| Z-0997-2019 | Class II | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; | June 21, 2018 |
| Z-0999-2019 | Class II | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ O | June 21, 2018 |
| Z-1004-2019 | Class II | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL | June 21, 2018 |
| Z-1001-2019 | Class II | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; | June 21, 2018 |
| Z-1003-2019 | Class II | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ R | June 21, 2018 |
| Z-1000-2019 | Class II | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ C | June 21, 2018 |
| Z-0998-2019 | Class II | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl | June 21, 2018 |
| Z-1002-2019 | Class II | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEM | June 21, 2018 |
| Z-1097-2014 | Class II | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees | October 15, 2012 |
| Z-0936-2014 | Class II | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees | February 12, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130174 | DVTCARE CA5 | May 2, 2013 |