Howmedica Osteonics Corp.: Medical Device Recall in 2018 - (Recall #: Z-2683-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

rHead Stem Implant 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.

Product Classification:

Class II

Date Initiated: October 24, 2017

Date Posted: August 15, 2018

Recall Number: Z-2683-2018

Event ID: 79315

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.

Status: Terminated

Product Quantity: 305

Code Information:

310-2016

Distribution Pattern:

Distribution US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated