Recall Z-1572-2026— Howmedica Osteonics Corp.

Name: FDA recall Z-1572-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-02

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2026-02-02. It names 2 FDA 510(k) clearances: K241011, K220459. Product: MICS3 Angled Sagittal Saw Attachment; Part Number: 210490. Reason: A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-02
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K241011 — Mako Total Knee ApplicationMako Surgical Corp.·cleared 2024-06-11
K220459 — Mako Total Knee ApplicationMako Surgical Corp.·cleared 2022-04-15

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

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

Reason for recall

A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

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