Recall Z-2828-2026— Stryker GmbH

Name: FDA recall Z-2828-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-01

Class II · Ongoing

Class II FDA medical device recall by Stryker GmbH, initiated 2026-07-01. It names one FDA 510(k) clearance: K033476. Product: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.. Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Ongoing
Initiated: 2026-07-01
Firm location: Selzach, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K033476 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEMHowmedica Osteonics Corp.·cleared 2004-01-20

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

Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.

Reason for recall

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

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