Recall Z-1621-2024— Howmedica Osteonics Corp.

Name: FDA recall Z-1621-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-27

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-02-27. It names one FDA 510(k) clearance: K171768. Product: TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B. Reason: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-27
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K171768 — Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics·cleared 2017-10-02

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

TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B

Reason for recall

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

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