FDA recall Z-2705-2018

Product

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.

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

Distribution US Nationwide.

Key facts

Status

Terminated

Initiation date

2017-10-24

Report date

2018-08-15

Termination date

2023-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2705-2018