Chisel (Osteotome)
FDA product code KDG · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery
11510(k) clearances
0PMA approvals
14recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952678 | Sta-Clear Alcohol-Free Endoscopic Anti-Fog KitKDG · Traditional | Avail-Southwest Division | 07/10/1995SE |
| K952200 | Omni-JugKDG · Traditional | Waterstone Medical, Inc. | 06/29/1995SE |
| K894785 | Surgical Chisel/OsteotomeKDG · Traditional | Fdt Precision Machine Co., Inc. | 08/18/1989SE |
| K891471 | Sil-Med Waste Fluid Dump BagKDG · Traditional | Sil-Med Corp. | 08/15/1989SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | Porex Medical | 08/21/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | Military Engineering, Inc. | 06/23/1987SE |
| K842824 | Chermel Bone ChiselsKDG · Traditional | Cher Mel Corp. | 08/02/1984SE |
| K772376 | Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772374 | Silver OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772373 | Anderson-Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K780135 | Cement Extraction Instrument SetKDG · Traditional | Orthopedic Equipment Co., Inc. | 01/31/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1019-2019 Class II | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical…There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and… | AAP Implantate Ag | 01/11/2019Terminated |
| Z-1360-2018 Class II | Normed Charcot Osteotome Chisel (Various sizes)Product may contain a gap between the handle and metal chisel which can lead to failure to properly… | Zimmer GmbH | 03/15/2018Terminated |
| Z-1920-2017 Class II | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1919-2017 Class II | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1918-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1917-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1916-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1915-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1914-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1913-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1912-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1911-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1910-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |
| Z-1909-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | Smith & Nephew, Inc. | 03/30/2017Terminated |