Heraeus, PALAMIX uno. Material Number: 66057893.

FDA device recall Z-1997-2026 · posted 2026-04-29 · Open, Classified

Recall details

Recalling firm

Heraeus Medical GmbH (Dental Division)

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).

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JDZ

Quantity affected

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, Germa

Date initiated

2026-03-25

Date posted

2026-04-29

Location

Wehrheim, Germany