U2 Total Knee System 2603-6051-RC
Listed
Valid until
Not applicable
FDA recalls
1 ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719886911688 | Date24 Feb 2026 | StatusListed |
Recalls
-
- Ongoing Z-2883-2026
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
-
- Terminated Z-1129-2018
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- U2 Total Knee System
- Generic Name
- Knee femur prosthesis trial, reusable
- Model / Ref / Catalog
- 2603-6051-RC
- Primary DI / UDI-DI
- 04719886911688
- 510(k) Number
- FDA Product Code
- JWH
- GMDN Term
- Knee femur prosthesis trial, reusable
- Device Class
- Class II
- Regulation Number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from United Orthopedic Corp.
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No