Device product
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Z-2068-2017
Product summary
- Event
- Event 77094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8154
- Official record key
device-enforcement:Z-2068-2017
Official wording
Reason: pegs shearing post-operatively
Code information: All lots of Model #'s: 141355 141356 141357 141358
Distribution pattern: US Nationwide.distribution and Canada.
Derived failure modes
-
Unknown
pegs shearing post-operatively