Home › Device types › KDG
Chisel (Osteotome)
FDA product code KDG · Class 1 · General, Plastic Surgery
1,385
Registered devices
16
Adverse events
14
Recalls
11
510(k) clearances
Devices with this code
Novo Surgical — NOVO SURGICAL, INC.Surgical Direct — Surgical Direct, Inc.NA — Exactech, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Comfort Plus Chisel Set — KOROS U.S.A., INC.Surgical Direct — Surgical Direct, Inc.Anmuth Medical International — Anmuth Medical International, LLCSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Osteotome — KOROS U.S.A., INC.Chisel — KOROS U.S.A., INC.Surgical Direct — Surgical Direct, Inc.STILLE Osteotomes — Stille ABSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Novo Surgical — NOVO SURGICAL, INC.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.