Home › Device types › LZK
Implant, Malar
FDA product code LZK · Class 2 · General, Plastic Surgery
3,825
Registered devices
61
Adverse events
4
Recalls
40
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, INCHTR-PMI — BIOMET MICROFIXATION, INCComposite Nasal Implant — IMPLANTECH ASSOCIATES, INC.HTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCePTFE Midfacial — IMPLANTECH ASSOCIATES, INC.ePTFE Paranasal — IMPLANTECH ASSOCIATES, INC.HTR-PMI — BIOMET MICROFIXATION, INCHTR-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 |
|---|---|---|
| 2025-09-26 | DSAART LLC | Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clear |
| 2007-07-24 | Spectrum Designs Inc | Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants |
| 2007-07-24 | Spectrum Designs Inc | Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant. |
| 2007-06-15 | Spectrum Designs Inc | The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was |
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