Screwdriver, Surgical

FDA product code LRZ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery

3510(k) clearances
0PMA approvals
6recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K896589Manual Surgical Instruments for Titamed AntwerpLRZ · Traditional Optik12/27/1989SE
K8724901.1 ScrewdriversLRZ · Traditional Micro-Aire Surgical Instruments, Inc.07/23/1987SE
K872387Standard Screw DriverLRZ · Traditional Med-Tool, Inc.07/16/1987SE

Recalls

RecallProductFirmInitiated
Z-0448-2016 Class IITray Set containing multiple instruments and may contain the flexible bone awl, flexible…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… Aesculap, Inc.11/10/2015Terminated
Z-0424-2016 Class IIFlexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… Aesculap, Inc.11/10/2015Terminated
Z-0423-2016 Class IIFlexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… Aesculap, Inc.11/10/2015Terminated
Z-0422-2016 Class IIFlexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… Aesculap, Inc.11/10/2015Terminated
Z-0040-2018 Class IIGenesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical…Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break… Genesys Orthopedics Systems, LLC11/05/2015Terminated
Z-1685-2013 Class IIIntegra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated…The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. Integra LifeSciences Corp.02/01/2013Terminated