Bone Cement
Orthopedic · 21 CFR 888.3027
Recent MDR events
13,130 adverse event reports on file
- DEPUY CMW 2G 20GJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13077
- DEPUY CMW 2G 20GJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13076
- CMW MARK III GUNJul 30, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-13033
- UNK - Biomaterial - CementJul 30, 2026InjurySynthes Gmbh8030965-2026-07851
- SMARTSETJul 29, 2026InjuryDepuy Ireland - 30155162661818910-2026-12936
- UNKNOWN BONE CEMENTJul 22, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12474
- UNK CEMENTJul 22, 2026InjuryDepuy Ireland - 30155162661818910-2026-12476
- BIOMET BC R 1X40 USJul 21, 2026InjuryBiomet France S.a.r.l.3006946279-2026-00030
- UNK CEMENTJul 20, 2026InjuryDepuy Ireland - 30155162661818910-2026-12268
- UNK CEMENTJul 20, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12276
Event type breakdown
Recalls
34 recall events for this product code
- Heraeus Medical GmbH (Dental Division)Open, ClassifiedJan 14, 2026
Brand Name: PALACOS
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.
Z-1080-2026 · View FDA record ↗ - Heraeus Medical GmbH (Dental Division)Open, ClassifiedJan 14, 2026
Brand Name: PALACOS
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.
Z-1081-2026 · View FDA record ↗ - Heraeus Medical GmbH (Dental Division)Open, ClassifiedJan 14, 2026
Brand Name: PALACOS
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.
Z-1082-2026 · View FDA record ↗ - Heraeus Medical GmbH (Dental Division)Open, ClassifiedJan 14, 2026
Brand Name: PALACOS
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.
Z-1083-2026 · View FDA record ↗ - Howmedica Osteonics Corp.Open, ClassifiedDec 20, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
Z-0736-2023 · View FDA record ↗ - Howmedica Osteonics Corp.Open, ClassifiedDec 20, 2022
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
Z-0737-2023 · View FDA record ↗ - BIOPSYBELL S.R.L.TerminatedMay 19, 2021
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Products labeled as sterile were distributed, but may not have been sterilized.
Z-1631-2021 · View FDA record ↗ - BIOPSYBELL S.R.L.TerminatedMay 19, 2021
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Products labeled as sterile were distributed, but may not have been sterilized.
Z-1632-2021 · View FDA record ↗ - BIOPSYBELL S.R.L.TerminatedMay 19, 2021
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Products labeled as sterile were distributed, but may not have been sterilized.
Z-1633-2021 · View FDA record ↗ - BIOPSYBELL S.R.L.TerminatedMay 19, 2021
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Products labeled as sterile were distributed, but may not have been sterilized.
Z-1635-2021 · View FDA record ↗
Registered firms
251 firms currently registered for this product code
Sterigenics U.s. Llc
Hayward, CA, US
Neo Spine Usa Inc.
Hackensack, NJ, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Merit Medical Uk Limited
Earley Reading, GB
Stryker Instruments
Portage, MI, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
Howmedica International S. De R.l.,
LIMERICK Munster, IE
Zimmer Pte. Ltd.
Singapore South East, SG
Arthrocare Corporation
Austin, TX, US
Sterigenics Uk Limited
Chesterfield Derbyshire, GB
Gammatom S.r.l.
GUANZATE (CO) Como, IT
Depuy Cmw
BLACKPOOL, LANCASHIRE, GB
G21 S.r.i.
San Possidonio Modena, IT
Encore Medical, L.p.
AUSTIN, TX, US
Merit Medical Systems, Inc.
South Jordan, UT, US
Sterox Srl
Castelfranco Piandisco Arezzo, IT
Zimmer Biomet Korea Ltd.
Seoul, KR
Depuy (ireland)
CO. CORK Munster, IE
Biomet, Inc.
WARSAW, IN, US
510(k) clearances
72 clearances for this product code
- Biomet FranceApr 15, 2026
K254107 · Refobacin Bone Cement R (110034355)
- Osteoremedies, LLCApr 2, 2025
K250760 · SPECTRUM GV Bone Cement
- Heraeus Medical GmbHDec 5, 2024
K241674 · OSTEOPAL® V
- Osteoremedies, LLCDec 20, 2023
K231556 · SPECTRUM® GV Bone Cement
- Tecres S.P.A.Jan 9, 2023
K211163 · Bone Cement Genta, Bone Cement HV, Bone Cement LV
- Biomecanica Industria E Comerciode Produtos Ortopedicos LtdaMay 31, 2022
K212729 · Bone Cement-Normal Viscosity
- Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VEMay 19, 2022
K211869 · OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
- Heraeus Medical GmbHFeb 2, 2022
K213812 · PALACOS MV pro
PMA approvals
7 premarket approvals for this product code
- Depuy, Inc.Feb 11, 1997
P960001 · DEPUY 1 BONE CEMENT
- Depuy, Inc.Feb 22, 1984
N18466 · CMW BONE CEMENT
- Smith & Nephew Richards, Inc.Feb 2, 1984
P810020 · PALACOS R BONE CEMENT
- L.D. Caulk Co.Sep 16, 1981
N17113 · OMNIPLASTIC BONE CEMENT
- Zimmer, Inc.May 17, 1976
N17755 · ZIMMER(R) BONE CEMENT
- Howmedica Corp.Oct 7, 1971
N17003 · SURGICAL SIMPLED P BONE CEMENT
- Howmedica Corp.Oct 7, 1971
N17004 · SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT