Z-3302-2026

PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl...

Name: Z-3302-2026 PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl...
Creator: Heraeus Medical GmbH (Dental Division)
Published: 2026-08-20
License: https://open.fda.gov/license/

Heraeus Medical GmbH (Dental Division) / initiated 2026-08-20 / Open, Classified

FDA source

Recall record

Recall number: Z-3302-2026
Status: Open, Classified
Initiated: 2026-08-20
Posted: 2026-09-25
Recalling firm: Heraeus Medical GmbH (Dental Division)
Product: PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. 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).
Product code: MBB Bone Cement, Antibiotic
Reason for recall: Potential for monomer liquid leakage.
FDA 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 procedures and local waste disposal guidelines. Additionally, consignees were instructed to keep a copy of the provided response form with your records in case your organization is subject to a compliance audit.
Quantity in commerce: 59,660 units
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.
Product codes and lots: Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.

Product code MBB

K210607Class IIPALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH / cleared 2021-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)