Home › Device types › KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
FDA product code KKY · Class 2 · General, Plastic Surgery
4,203
Registered devices
215
Adverse events
9
Recalls
25
510(k) clearances
Devices with this code
HTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCOmniPore Surgical Implant — MATRIX SURGICAL HOLDINGS, LLCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.Biopor® — CEREMED, INC.HTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-30 | Matrix Surgical Holdings, LLC | Product mislabeling. |
| 2019-01-30 | Matrix Surgical Holdings, LLC | Product mislabeling. |
| 2017-01-25 | Matrix Surgical Holdings, LLC | Mislabeling. The packaging labeled as left mandible contained a right mandible. |
| 2016-06-13 | Biomet Microfixation, LLC | Potential sterility deficiency. |
| 2013-12-06 | Stryker Howmedica Osteonics Corp. | Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
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