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Prosthesis, Chin, Internal
FDA product code FWP · Class 2 · General, Plastic Surgery
4,497
Registered devices
240
Adverse events
5
Recalls
66
510(k) clearances
Devices with this code
HTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCTerino Square Chin - Style II Sizers — 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, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCChin Implant — IMPLANTECH ASSOCIATES, INC.Spectrum Designs Medical — SPECTRUM DESIGNS INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCHTR-PMI — BIOMET MICROFIXATION, INCAART Chin Implant Sizer — AartOsteoVation — SKELETAL KINETICS LLCHTR-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 |
| 2014-12-17 | Stryker Craniomaxillofacial Division | Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaki |
| 2014-12-17 | Stryker Craniomaxillofacial Division | Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaki |
| 2014-12-17 | Stryker Craniomaxillofacial Division | Potential for implant damage, implant cracking off/breaking intra-operatively. |
| 2013-08-30 | Implantech Associates Inc | Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices fro |
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