Z-2068-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- March 22, 2017
- Termination Date
- October 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8154
Product Description
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.
Reason for Recall
pegs shearing post-operatively
Distribution Pattern
US Nationwide.distribution and Canada.
Code Information
All lots of Model #'s: 141355 141356 141357 141358