Heraeus Medical GmbH (Dental Division) recalls PALACOS R+G pro 40
Reason for recall
Potential for monomer liquid leakage.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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 information
- Lot #
- Code:
- UDI
- 04260102136182; 04260102136212. All Batch Numbers. All
What the firm is doing
Heraeus Medical notified consignees on about 08/20/2026 via emailed letter. Consignees were informed of the issue and risk and were instructed to read the Correction Letter carefully and ensure that all relevant hospital departments are made aware of its contents, ensure that suitable eye protection is worn whenever the system is being operated, and complete and return the provided reply form. If any leakage is observed, do not continue to use the product. Instead, discard it with additional precautions, such as wearing double gloves (e.g. nitrile rubber), in accordance with internal hospital procedures and local waste disposal guidelines. Additionally, consignees were instructed to keep a copy of the provided response form with your records in case your organization is subject to a compliance audit.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3302-2026
- FDA 510(k) clearance · K210607The device's official FDA premarket clearance record
- FDA device classification · MBBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3027The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Heraeus Medical GmbH (Dental Division)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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