rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Recall
- Recall Number
- Z-2705-2018
- Event Number
- 79315
- Firm
- Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- JDB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 24, 2017
- Terminated
- May 18, 2023
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006
Description
rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
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.
On October 27, 2017 an URGENT MEDICAL RECALL NOTIFICATION was issued to customers titled Product Field Action PR 1642784. The letter requests that recipients notify all necessary individuals within their organization of the recall and that a Stryker trauma representative will collect any affected product from the customer location. Questions or concerns can be directed to 201-831-6693
Distribution US Nationwide.
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