Recall Z-0044-2025— Howmedica Osteonics Corp.

Name: FDA recall Z-0044-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-07

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-08-07. It names one FDA 510(k) clearance: K093425. Product: MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063. Reason: Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-07
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K093425 — MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THAMako Surgical Corp.·cleared 2010-02-24

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

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Reason for recall

Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

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