#4 Bipolar stem implant recall
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
Why was #4 Bipolar stem implant recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
RCN-S4
- Product
- #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 387
- Distribution
- Distribution US Nationwide.
- Recall date
- August 15, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)