Vanguard Removable Molded Poly Tibia SSI002122
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00880304989153 | Date3 May 2017 | StatusListed |
Recalls
-
- Terminated Z-2151-2020
- Terminated Z-2152-2020
Potential presence of elevated endotoxin levels that exceed the specification limit
-
- Terminated Z-1861-2017
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Vanguard Removable Molded Poly Tibia
- Generic Name
- Knee tibia prosthesis trial, reusable
- Model / Ref / Catalog
- SSI002122
- Primary DI / UDI-DI
- 00880304989153
- 510(k) Number
- FDA Product Code
- JWH
- GMDN Term
- Knee tibia 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 Biomet Orthopedics, Inc.
Properties
Other properties (13)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No