Z-2727-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2018
- Initiation Date
- October 24, 2017
- Termination Date
- May 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 544
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distribution US Nationwide.
Code Information
RHA-S2