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The official notice did not include a photo. Check the product details and identifiers below.
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PALACOS R pro 40; PALACOS R pro 80. Model Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone
Official notice
7 Oct 2026
Last checked
13 Oct 2026
An official FDA notice concerns Heraeus Medical. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-10-07. Recall numbers: Z-3301-2026. Check the official notice for the complete list.
What to do now
Instructions for consumers are available in the official FDA notice.
Units affected
33,727
Recall number
Z-3301-2026
Official notice
2026-10-07
The hazard
The hazard
Health risk requiring medical assessment
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Heraeus Medical. Contact: Heraeus Medical GmbH (Dental Division).
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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