Z-2664-2018 Class II Terminated
FDA device recall Z-2664-2018 was initiated by Howmedica Osteonics Corp. on October 24, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 18, 2023). Affected quantity: 396.
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
- 396
Product Description
Lateral Assembly, Radial Stem Implant, Size 2. 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
310-0001