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PALACOS recallZ-3303-2026 · Heraeus Medical GmbH (Dental Division) · initiated Aug 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heraeus Medical GmbH (Dental Division) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for monomer liquid leakage.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-3303-2026
Status
Open, Classified
Initiated by the company
Aug 20, 2026
Posted by the FDA
Sep 25, 2026
Recalling firm
Heraeus Medical GmbH (Dental Division)
Quantity
20,523 units
Product code
MBB
FDA submissions
K210607
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 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

Code information (models, lots, serial numbers)

Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K210607 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99708).

Sources and updates

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