FDA Device Intelligence
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Bit, Surgical

FDA product code GFG · Class 1 · General, Plastic Surgery

1,316
Registered devices
683
Adverse events
17
Recalls
3
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.