Cement, Ear, Nose And Throat
Dental · 21 CFR 872.3275
Recent MDR events
49 adverse event reports on file
- 2G OTOMIMIXMar 31, 2025MalfunctionBiomet Microfixation0001032347-2025-00182
- 2G OTOMIMIXMar 28, 2025MalfunctionBiomet Microfixation0001032347-2025-00180
- OTOMIMIX CALCIUM PHOSPHATEDec 31, 2024MalfunctionBiomet Microfixation0001032347-2024-00418
- 2G OTOMIMIXNov 27, 2024MalfunctionBiomet Microfixation0001032347-2024-00357
- OTOMIMIX CALCIUM PHOSHPATEMar 26, 2024MalfunctionBiomet Microfixation0001032347-2024-00105
- 2G OTOMIMIXMar 1, 2024InjuryBiomet Microfixation0001032347-2024-00063
- 2G OTOMIMIXMar 1, 2024InjuryBiomet Microfixation0001032347-2024-00064
- 2G OTOMIMIXDec 19, 2023MalfunctionBiomet Microfixation0001032347-2023-00471
- 2G OTOMIMIXDec 19, 2023MalfunctionBiomet Microfixation0001032347-2023-00472
- OTOMIMIX CALCIUM PHOSPHATE BONE VOIDDec 1, 2023MalfunctionBiomet Microfixation0001032347-2023-00448
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
Biomet Microfixation
Jacksonville, FL, US
Sterigenics U.s., Llc
Corona, CA, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Invotec International, Inc.
Jacksonville, FL, US
Ototronix, Llc (minnesota)
White Bear Township, MN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations, Inc.
Libertyville, IL, US
Envoy Medical Corporation
White Bear Lake, MN, US
Gyrus Acmi, Inc.
BARTLETT, TN, US
510(k) clearances
6 clearances for this product code
- Ototronix, LLCJun 19, 2014
K140644 · PROCEM
- Envoy Medical CorporationFeb 28, 2008
K080032 · ENVOYCEM, MODEL 1640
- Stryker CmfApr 19, 2006
K060750 · STRYKER INJECTABLE CEMENT
- Walter Lorenz Surgical, Inc.Nov 8, 2004
K042516 · OTOMIMIX
- Ototech, Inc.Sep 13, 2001
K011338 · OTO-CEM
- Corinthian Medical , Ltd.Feb 12, 2001
K003567 · SERENOCEM, MODEL BC 010