FDAFDA · Food and drugs·Recall number Z-2714-2018
#1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Published August 15, 2018 · Recall initiated: October 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- Distribution US Nationwide.
- Lot
- RCN-S1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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