Home › Device types › KDG
Chisel (Osteotome)
FDA product code KDG · Class 1 · General, Plastic Surgery
1,391
Registered devices
16
Adverse events
14
Recalls
11
510(k) clearances
Devices with this code
Surgical Direct — Surgical Direct, Inc.ELMED — ELMED INCORPORATEDComfort Plus Chisel — KOROS U.S.A., INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Osteotome — KOROS U.S.A., INC.Surgical Direct — Surgical Direct, Inc.ELMED — ELMED INCORPORATEDSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Husky Plus Chisel — KOROS U.S.A., INC.Life Instruments — Life Instrument CorporationLINK Instruments - Chisel, bone curette, raspatory, rongeur — WALDEMAR LINK GmbH & Co. KGLINK Instruments - Chisel, bone curette, raspatory, rongeur — WALDEMAR LINK GmbH & Co. KGPRINCETON — Princeton Medical Group, Inc.Quinelato — Schobell Industrial LtdaSurgical Direct — Surgical Direct, Inc.Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC.ELMED — ELMED INCORPORATEDLife Instruments — Life Instrument CorporationLife Instruments — Life Instrument CorporationORTHOMED — ORTHO-MED, INC.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.ELMED INCORPORATED — ELMED INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-11 | AAP Implantate Ag | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate. |
| 2018-03-15 | Zimmer GmbH | Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
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