Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3301-2026%22

Class II recall Z-3301-2026: Heraeus Medical GmbH (Dental Division)

Q: How to monitor Class II recall Z-3301-2026: Heraeus Medical GmbH (Dental Division) and peer other records

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Class II recall Z-3301-2026: Heraeus Medical GmbH (Dental Division): Heraeus Medical GmbH (Dental Division). Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-3301-2026
Recalling firm	Heraeus Medical GmbH (Dental Division)
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. 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).
Reason	Potential for monomer liquid leakage.
Quantity	33,727 units
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.
Recall initiated	2026-08-20
Reported	2026-10-07
Firm location	Wehrheim, Germany
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-07
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 28 days ago.

What is the FDAPulse record for Class II recall Z-3301-2026: Heraeus Medical GmbH (Dental Division)?

Class II device recall Z-3301-2026 by Heraeus Medical GmbH (Dental Division): Potential for monomer liquid leakage.

How does Class II recall Z-3301-2026: Heraeus Medical GmbH (Dental Division) compare to other FDAPulse records?

It is 28 days old, still within a typical 45-day follow-up window.

Class II recall Z-3301-2026 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-3301-2026		2026-10-07
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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