Recall Z-3303-2026— Heraeus Medical GmbH (Dental Division)

Name: FDA recall Z-3303-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Class II · Ongoing

Class II FDA medical device recall by Heraeus Medical GmbH (Dental Division), initiated 2026-08-20. It names one FDA 510(k) clearance: K210607. Product: PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A. Reason: Potential for monomer liquid leakage..

Recalling firm: Heraeus Medical GmbH (Dental Division)
Classification: Class II
Status: Ongoing
Initiated: 2026-08-20
Firm location: Wehrheim, Germany

510(k) clearances named in this recall

1 on FDA's record

K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH·cleared 2021-07-09

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

PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

Reason for recall

Potential for monomer liquid leakage.

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