Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software V
FDA device recall Z-1083-2026 · posted 2026-01-14 · Open, Classified
Recall details
- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LOD
- Distribution
- International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, S
- Date initiated
- 2025-12-09
- Date posted
- 2026-01-14
- Location
- Wehrheim, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALACOS MV pro (K213812) | Heraeus Medical GmbH | 2022-02-02 |