Corail 3L93720
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10603295168959 | Date24 Mar 2015 | StatusListed |
Recalls
-
- Terminated Z-2521-2018
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Corail
- Generic Name
- Coated femoral stem prosthesis, one-piece
- Model / Ref / Catalog
- 3L93720
- Primary DI / UDI-DI
- 10603295168959
- FDA Product Code
- MEH, LZO, KWL, KWY
- GMDN Term
- Coated femoral stem prosthesis, one-piece
- Device Class
- Class II
- Regulation Number
- 888.3353, 888.3360, 888.3390
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Conditional
Other devices from Depuy (Ireland)
Properties
Other properties (8)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No