Recall Z-3301-2026— Heraeus Medical GmbH (Dental Division)

Name: FDA recall Z-3301-2026
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 R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. 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).. 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 R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. 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).

Reason for recall

Potential for monomer liquid leakage.

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