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U.S. Department of Health and Human Services

Class 2 Device Recall PALACOS MV pro 40; PALACOS MV pro 80

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 Class 2 Device Recall PALACOS MV pro 40; PALACOS MV pro 80see related information
Date Initiated by FirmDecember 09, 2025
Date PostedJanuary 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1083-2026
Recall Event ID 98078
510(K)NumberK213812 
Product Classification Bone cement - Product Code LOD
ProductBrand 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
Code Information Lot Code: UDI-DI: 04260102135338; 04260102135369
Recalling Firm/
Manufacturer		 Heraeus Medical GmbH (Dental Division)
Philipp-Reis-Str. 8
Wehrheim Germany
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
DistributionInternational 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LOD
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