PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate
Summary
The FDA issued a Class II for PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. by Heraeus Medical GmbH (Dental Division). Reason: Potential for monomer liquid leakage..
Details
Source
Device Recall
External ID
Z-3302-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. 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).
Lot/Code Info: Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.
Quantity Affected: 59,660 units
Reason for Recall
Potential for monomer liquid leakage.
Distribution
Worldwide 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-20
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Heraeus Medical GmbH (Dental Division) has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heraeus Medical GmbH (Dental Division)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heraeus Medical GmbH (Dental Division) have FDA actions?
Heraeus Medical GmbH (Dental Division) has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3302-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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