Device product
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Z-2727-2018
Product summary
- Event
- Event 79315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 544
- Official record key
device-enforcement:Z-2727-2018
Official wording
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Code information: RHA-S2
Distribution pattern: Distribution US Nationwide.
Derived failure modes
-
Unknown
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.