rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reported: August 15, 2018 Initiated: October 24, 2017 #Z-2706-2018
Product Description
rHead Standard Extended Stem, 6mm Collar, Size 4. 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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 36
- Distribution
- Distribution US Nationwide.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.. Recalled by Howmedica Osteonics Corp.. Units affected: 36.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2018. Severity: Moderate. Recall number: Z-2706-2018.
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