Recall Z-2713-2018— Howmedica Osteonics Corp.

Name: FDA recall Z-2713-2018
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: K023604. Product: #4 Bipolar radial head Implant (Sterile packed). 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

K023604 — MODIFICATION TO RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc.·cleared 2002-11-27

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

#4 Bipolar radial head Implant (Sterile packed). 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.