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U.S. Department of Health and Human Services

Class 3 Device Recall PALAMIX duo

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 Class 3 Device Recall PALAMIX duosee related information
Date Initiated by FirmMarch 25, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1998-2026
Recall Event ID 98608
Product Classification Mixer, cement, for clinical use - Product Code JDZ
ProductHeraeus, PALAMIX duo. Material Number: 66057897.
Code Information Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
FEI Number 3006406161
Recalling Firm/
Manufacturer		 Heraeus Medical GmbH (Dental Division)
Philipp-Reis-Str. 8
Wehrheim Germany
Manufacturer Reason
for Recall		Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 03/25/2026 Field Safety Notice letters 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.
Quantity in Commerce1,125 units
DistributionWorldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;
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.
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