Z-1083-2026Class II

Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635...

Name: Z-1083-2026 Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635...
Creator: Heraeus Medical GmbH (Dental Division)
Published: 2025-12-09
License: https://open.fda.gov/license/

Heraeus Medical GmbH / initiated 2025-12-09 / Open, Classified

FDA source

Heraeus Medical GmbH (Dental Division) began a recall of Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description... on 2025-12-09. FDA classified it as Class II and gives the reason as "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1083-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-09
Posted: 2026-01-14
Recalling firm: Heraeus Medical GmbH
Product: Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: 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). Component: N/A
Product code: LOD Bone Cement
Reason for recall: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
FDA root cause: Under Investigation by firm
Action: On December 9, 2025 Urgent Field Safety Notice emails 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 [email protected] 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. 4. Heraeus Medical GmbH is fully cooperating with regulatory authorities and is committed to resolving this issue efficiently. For further details regarding this field safety notice, please contact your Heraeus Medical sales representative or distributor. We regret any inconvenience caused by this action and value your cooperation and commitment to patient safety. This field safety notice was submitted to the FDA in context of the correction authority report.
Distribution: International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Product codes and lots: Lot Code: UDI-DI: 04260102135338; 04260102135369

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1083-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1080-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1081-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1082-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1083-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14

Product code LOD

K213812Class IIPALACOS MV proHeraeus Medical GmbH / cleared 2022-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)