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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 FirmAugust 20, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3304-2026
Recall Event ID 99708
510(K)NumberK213812 
Product Classification Bone cement - Product Code LOD
ProductPALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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. All Batch Numbers. All Lot Numbers.
FEI Number 3006406161
Recalling Firm/
Manufacturer		 Heraeus Medical GmbH (Dental Division)
Philipp-Reis-Str. 8
Wehrheim Germany
Manufacturer Reason
for Recall		Potential for monomer liquid leakage.
FDA Determined
Cause 2		Under Investigation by firm
ActionHeraeus 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.
DistributionWorldwide 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.
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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