Instrument, Cutting, Orthopedic
FDA product code HTZ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
21510(k) clearances
0PMA approvals
14recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933933 | CeboplaneHTZ · Traditional | Synvasive Technology, Inc. | 04/15/1994SE |
| K931737 | Hedleyl Intramedullary Preparation BrushHTZ · Traditional | Synvasive Technology, Inc. | 01/07/1994SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | Bowen & Company, Inc. | 03/23/1987SE |
| K853678 | Kambin Spinal Instrument SetHTZ · Traditional | Pilling Co. | 09/24/1985SE |
| K850527 | Arthroscopy Suction Biopsy PunchHTZ · Traditional | T. Korossurgical Instruments Corp. | 03/14/1985SE |
| K850423 | Concept Suction SleeveHTZ · Traditional | Concept, Inc. | 03/14/1985SE |
| K841980 | Side Cutting Serrated BladeHTZ · Traditional | Stainless Mfg., Inc. | 08/15/1984SE |
| K842774 | Codman Suction Punch-Product CodesHTZ · Traditional | Codman & Shurtleff, Inc. | 07/27/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | J. Sklar Mfg. Co., Inc. | 06/19/1984SE |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841978 | Lateral Release Knife 5MM & 7MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841977 | 5MM Dougle Edge Ring CuretteHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841976 | Hook Knife 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841975 | Rosette Knife 4MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841974 | Retrograde Knife 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841973 | Banana Knife SerratedHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841972 | Banana Knife - K841969-LABELINGHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K831772 | Guillotine BladeHTZ · Traditional | Ortho Pared Instruments, Inc. | 07/07/1983SE |
| K771915 | Micro Oscillating SawHTZ · Traditional | American Sterilizer Co. | 10/21/1977SE |
| K771006 | Modified Podiatry ProductsHTZ · Traditional | Dentronix, Inc. | 06/17/1977SE |
| K771005 | New Podiatry ProductsHTZ · Traditional | Dentronix, Inc. | 06/17/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1169-2020 Class II | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral…The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. | DePuy Orthopaedics, Inc. | 01/03/2020Terminated |
| Z-2345-2015 Class II | Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.Saw head separated from the drive unit or began to come loose. | The Anspach Effort, Inc. | 07/01/2015Terminated |
| Z-1781-2014 Class II | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate…It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the… | Synthes, Inc. | 04/22/2014Terminated |
| Z-2199-2013 Class II | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are…Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating… | Tornier, Inc | 08/13/2013Terminated |
| Z-0882-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0881-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 80 mm, Biomet…The Falling component: universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0880-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0879-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0878-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0877-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0876-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0875-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0874-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |
| Z-0873-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet…Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen… | Biomet, Inc. | 12/18/2008Terminated |