Recall Z-3304-2026— Heraeus Medical GmbH (Dental Division)
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: K213812. Product: PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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 recordK-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 pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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.