Cement Obturator
General, Plastic Surgery · 21 CFR 878.3300
Recent MDR events
212 adverse event reports on file
- QUIRURFIXJul 20, 2026DeathTeknimed Sas3003854593-2026-00003
- STRYKER BIO PREP AND BONE PREPARATION KITMay 18, 2026InjuryStryker Corp./howmedica Osteonic Corp.MW5188383
- CEMENT RESTRICTOR DIA.24MMMay 6, 2026InjuryTornier S.a.s.3000931034-2026-00400
- CEMENT RESTRICTOR DIA.13MMMay 6, 2026InjuryTornier S.a.s.3000931034-2026-00401
- PREP IM ENCHANCE TOTAL HIP KITApr 5, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-00468
- BUCK FEM CEMENT RSTR 25MMApr 2, 2026InjurySmith & Nephew, Inc.1020279-2026-00463
- BUCK CEMENT RSTR 18.5Mar 30, 2026InjurySmith & Nephew, Inc.1020279-2026-00420
- CEMENT RESTRICTOR 25MMFeb 23, 2026InjurySmith & Nephew, Inc..MW5184159
- PREP IM ENCHANCE TOTAL HIP KITFeb 2, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-00147
- BUCK FEMORAL CEMENT RESTRICTOR 18.5MMJan 29, 2026InjurySmith & Nephew, Inc.MW5183070
Event type breakdown
Recalls
8 recall events for this product code
- Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process.
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2596-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2597-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the proce
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2598-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum t
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2599-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacu
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2600-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant hi
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2601-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedSep 19, 2023
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a const
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Z-2602-2023 · View FDA record ↗ - Depuy Ireland UCOpen, ClassifiedJan 12, 2023
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
Z-0951-2023 · View FDA record ↗
Registered firms
86 firms currently registered for this product code
Stryker Ireland Osteonics
Cork Cork (County), IE
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Ionisos
SABLE-SUR-SARTHE, FR
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Howmedica Osteonics Corp
MAHWAH, NJ, US
Zimmer, Inc.
WARSAW, IN, US
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Zimmer Manufacturing B.v.
MERCEDITA, PR, US
Sterigenics Us Llc
West Memphis, AR, US
Nelipak Healthcare Packaging
CLARA, Offaly, IE
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Johnson & Johnson Medical (depuy - Suzhou) Ltd.
SUZHOU Jiangsu, CN
Tornier S.a.s.
Montbonnot Saint-Martin Isere, FR
Zimmer Biomet Korea Ltd.
Seoul, KR
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Polymer Corporation
Middletown, CT, US
Isomedix Operations Inc.
Northborough, MA, US
Sterigenics U.s., Llc
Atlanta, GA, US
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Smith & Nephew, Inc.
MEMPHIS, TN, US
Stryker Instruments
Portage, MI, US
510(k) clearances
37 clearances for this product code
- Howmedica Osteonics, Dba Stryker OrthopaedicsMay 20, 2022
K220838 · Artisan Bone Plug, Universal Cement Restrictor
- TornierSep 14, 2006
K061824 · TORNIER CEMENT RESTRICTOR
- Teknimed, S.A.Nov 26, 2003
K032685 · CEMSTOP CEMENT RESTRICTOR
- Smith & Nephew, Inc.Nov 19, 2002
K023680 · BIOBUCK CEMENT RESTRICTOR
- Kensey Nash Corp.Sep 19, 2001
K011943 · IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
- Isotis NVApr 20, 2001
K010840 · SYNPLUG
- Encore Orthopedics, Inc.May 4, 2000
K993841 · CEMSTOP CEMENT RESTRICTOR
- Isotis NVMay 4, 2000
K000587 · SHUTTLE STOP