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PALACOS®

Heraeus Medical GmbH · Model R+G · UDI-DI 04260102135536

MBB LOD Prescription

510(k) clearances

3,709

Adverse events (49 deaths)

Recalls

Facilities

Description

PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.

Recalls

Date	Firm	Reason
2026-08-20	Heraeus Medical GmbH (Dental Division)	Potential for monomer liquid leakage.
2026-08-20	Heraeus Medical GmbH (Dental Division)	Potential for monomer liquid leakage.
2022-10-21	Howmedica Osteonics Corp.	Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
2015-02-11	DePuy Orthopaedics, Inc.	One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
2013-11-04	Zimmer, Inc.	The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
2013-09-16	DePuy Orthopaedics, Inc.	The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated
2006-11-07	Stryker Howmedica Osteonics Corp.	The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.