Recall Z-3304-2026 ยท LOD Bone Cement
Heraeus Medical GmbH (Dental Division)
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
| Date | Sep 25, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| Reason | Potential for monomer liquid leakage. |
| Root cause | Under Investigation by firm |
| Action | Heraeus Medical notified consignees on about 08/20/2026 via emailed letter. Consignees were informed of the issue and risk and were instructed to read the Correction Letter carefully and ensure that all relevant hospital departments are made aware of its contents, ensure that suitable eye protection is worn whenever the system is being operated, and complete and return the provided reply form. If any leakage is observed, do not continue to use the product. Instead, discard it with additional precautions, such as wearing double gloves (e.g. nitrile rubber), in accordance with internal hospital |
| Distribution | Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213812 | PALACOS MV pro Heraeus Medical GmbH, Feb 2, 2022 |