FDA Medical Device Recalls (openFDA)
Heraeus Medical GmbH (Dental Division): Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 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
- Recall number
- Z-1083-2026
- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Product
- Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 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
- Status
- Open, Classified
- Initiated
- 2025-12-09
- Posted
- 2026-01-14
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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 hm.fsca.medical@heraeus.com 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Lot Code: UDI-DI: 04260102135338; 04260102135369
- 510(k) numbers
- ["K213812"]
- PMA numbers
- not on file
- Product code
- LOD
- Firm FEI
- 3006406161
- Firm city
- Wehrheim
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28