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PALACOS recallZ-1082-2026 · Heraeus Medical GmbH (Dental Division) · initiated Dec 9, 2025

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

increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.

FDA root cause category: Under Investigation by firm

What the company is doing

On December 9, 2025 Urgent Field Safety Notice emails were sent to customers. Actions to be taken: 1. Read this Field Safety Notice and ensure that all relevant hospital departments are informed about its content. 2. Please complete the attached customer reply form and send it to [email protected] within five (5) calendar days. This form must be returned even if you no longer use the device. 3. Keep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility. 4. Heraeus Medical GmbH is fully cooperating with regulatory authorities and is committed to resolving this issue efficiently. For further details regarding this field safety notice, please contact your Heraeus Medical sales representative or distributor. We regret any inconvenience caused by this action and value your cooperation and commitment to patient safety. This field safety notice was submitted to the FDA in context of the correction authority report.

Recall details

Recall number
Z-1082-2026
Status
Open, Classified
Initiated by the company
Dec 9, 2025
Posted by the FDA
Jan 14, 2026
Recalling firm
Heraeus Medical GmbH (Dental Division)
Product code
LOD
FDA submissions
K210607
Distribution
International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.

Product description

Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: 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

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 98078).

Sources and updates

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