Recall Z-1997-2026 ยท JDZ Mixer, Cement, For Clinical Use
Heraeus Medical GmbH (Dental Division)
Heraeus, PALAMIX uno. Material Number: 66057893.
| Date | Apr 29, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Under Investigation by firm |
| Action | On 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 | 51,771 units |
| Distribution | Worldwide 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.