Bone Cement, Antibiotic
Orthopedic · 21 CFR 888.3027
Recent MDR events
3,697 adverse event reports on file
- SMARTSETJul 30, 2026InjuryDepuy Ireland - 30155162661818910-2026-13060
- SMARTSETJul 30, 2026InjuryDepuy Ireland - 30155162661818910-2026-13061
- REFOBACIN BONE CEMENT R 1X40-3Jul 27, 2026InjuryBiomet France S.a.r.l.3006946279-2026-00032
- REFOBACIN BONE CEMENT R 1X40-3Jul 22, 2026MalfunctionBiomet France S.a.r.l.3006946279-2026-00031
- SMARTSETMV MV ENDURANCE 40 GJul 17, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-12172
- SMARTSETJul 15, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11964
- SMARTSETJul 14, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11928
- UNK CEMENT SMARTSETJul 14, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-11933
- SMARTSET GHV GENTAMICIN 40GJul 14, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-11953
- SMARTSET GHV GENTAMICIN 20GJul 14, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-11954
Event type breakdown
Recalls
5 recall events for this product code
- Howmedica Osteonics Corp.Open, ClassifiedNov 15, 2022
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin
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)
Z-0240-2023 · View FDA record ↗ - DePuy Orthopaedics, Inc.TerminatedMar 5, 2015
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or
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.
Z-1246-2015 · View FDA record ↗ - Zimmer, Inc.TerminatedJan 13, 2014
Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Dis
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.
Z-0730-2014 · View FDA record ↗ - DePuy Orthopaedics, Inc.TerminatedOct 23, 2013
SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile.
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 in the IFU for the SmartSet GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia
Z-0064-2014 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedJan 10, 2007
Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
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 longer expiration date than the actual subcomponents will support.
Z-0467-2007 · View FDA record ↗
Registered firms
146 firms currently registered for this product code
Isomedix Operations, Inc.
Libertyville, IL, US
Sterox Srl
Castelfranco Piandisco Arezzo, IT
Biomet, Inc.
WARSAW, IN, US
G21 S.r.i.
San Possidonio Modena, IT
Zimmer Pte. Ltd.
Singapore South East, SG
Gammatom S.r.l.
GUANZATE (CO) Como, IT
Depuy (ireland)
CO. CORK Munster, IE
Zimmer Biomet Centroamerica Sa
san jose, CR
Howmedica Osteonics Corp
MAHWAH, NJ, US
Sterigenics Us, Llc
Lewis Center, OH, US
Depuy Cmw
BLACKPOOL, LANCASHIRE, GB
Steril Verona S.r.l.
ERBE Verona, IT
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Medacta International Sa
Castel San Pietro Ticino, CH
Sterigenics U.s., Llc
Salt Lake City, UT, US
Osteoremedies, Llc
Memphis, TN, US
Heraeus Medical Llc
Yardley, PA, US
510(k) clearances
19 clearances for this product code
- G21, S.R.L.Sep 15, 2025
K252443 · SpaceFix Shoulder Spacer
- Teknimed SasDec 18, 2024
K242216 · GENTAFIX® (1, 3, 3MV)
- Osartis GmbHNov 20, 2024
K240856 · Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
- Biomet, Inc.Dec 28, 2022
K222760 · StageOne Select Hip Cement Spacer Molds
- Biomet, Inc.Sep 15, 2022
K221968 · StageOne Shoulder Cement Spacer Molds
- Biomet, Inc.Sep 2, 2022
K213287 · StageOne Knee Cement Spacer Molds
- G21, S.R.L.Feb 17, 2021
K202338 · SpaceFlex Shoulder
- G21, S.R.L.Aug 13, 2020
K201960 · SpaceFlex Knee - 80mm Size