Active Articulation™ Dual Mobility Hip System XL-200166
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00880304491434 | Date24 Oct 2015 | StatusListed |
Recalls
-
- Terminated Z-1024-2017
- Terminated Z-1025-2017
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Active Articulation™ Dual Mobility Hip System
- Generic Name
- Constrained polyethylene acetabular liner
- Model / Ref / Catalog
- XL-200166
- Primary DI / UDI-DI
- 00880304491434
- FDA Product Code
- OQG, LZO, KWY, LPH
- GMDN Term
- Constrained polyethylene acetabular liner
- Device Class
- Class II
- Regulation Number
- 888.3358, 888.3353, 888.3390
- GUDID distribution status
- In Commercial Distribution
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (7)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No