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Driver, Wire, And Bone Drill, Manual
FDA product code DZJ · Class 2 · Dental
925
Registered devices
3,399
Adverse events
11
Recalls
32
510(k) clearances
Devices with this code
N/A — BIOMET MICROFIXATION, INCIPS — KLS-Martin L.P.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.N/A — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INCDELTA — Stryker Leibinger GmbH & Co. KGTRUMATCH — Materialise NVVSP System — 3D SYSTEMS, INC.DELTA — Stryker Leibinger GmbH & Co. KGNA — Synthes GmbHIPS — KLS-Martin L.P.N/A — BIOMET MICROFIXATION, INCMaterialise Mimics Enlight CMF — Materialise NVAccuPlan System — MedcadNA — Synthes GmbHDELTA — Stryker Leibinger GmbH & Co. KGIPS — KLS-Martin L.P.IPS — KLS-Martin L.P.AccuPlan System — MedcadN/A — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INCAccuPlan System — Medcad
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-17 | Medical Modeling, Inc. | Scapula Marking Guide (anatomically Shaped) was incorrectly designed. |
| 2013-10-02 | Stryker Instruments Div. of Stryker Corporation | It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, s |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to th |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to th |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to th |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to th |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to th |
| 2006-01-30 | Straumann Manufacturing Inc. | Pilot drills may not fully extend through drill guide in template products |
| 2006-01-30 | Straumann Manufacturing Inc. | Pilot drills may not fully extend through drill guide in template products |
| 2005-08-05 | Stryker Instruments Div. of Stryker Corporation | Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current. |
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