VerSys® 65-7845-09
by Zimmer, Inc.
VerSys® 65-7845-09 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K980711 on 12 Nov 1998 and listed in FDA GUDID since 2 Oct 2017 (UDI-DI 00889024366589), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024366589 | Date2 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980711 | Date12 Nov 1998 | StatusActive |
Official records
- AccessGUDID record 00889024366589
- FDA 510(k) database K980711
Across registries
- FDA 510(k) K980711 decided 12 Nov 1998 Active
- FDA GUDID UDI-DI 00889024366589 listed 2 Oct 2017 Listed
Recalls
-
- Terminated Z-0770-2013
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Timeline
- Cleared FDA 510(k) K980711
- Recall initiated FDA recalls Z-0770-2013
- Listed FDA GUDID 00889024366589
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VerSys®
- Generic name
- Coated hip femur prosthesis, modular
- Model / reference
- 65-7845-09
- Primary DI / UDI-DI
- 00889024366589
- 510(k) Number
- FDA product code
- MEH, LPH
- GMDN term
- Coated hip femur prosthesis, modular
- Device class
- Class II
- Regulation number
- 888.3353, 888.3358
- GUDID distribution status
- In Commercial Distribution