Recall Z-2694-2018— Howmedica Osteonics Corp.

Name: FDA recall Z-2694-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-24

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2017-10-24, terminated 2023-05-18. It names one FDA 510(k) clearance: K060038. Product: Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.. Reason: 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..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Terminated: 2023-05-18
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K060038 — SBI RADIO-CAPITELLAR IMPLANTSmall Bone Innovations, Inc.·cleared 2006-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Radio Capitellum Small, Left. 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.