Aesculap Implant Systems recalls

Aesculap Implant Systems appears in 62 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO…
  FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems
  Reason: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
• GP321R
  FDA Device · Class II · 2017-05-24 · Aesculap Implant Systems
  Reason: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also…
• GP161R
  FDA Device · Class II · 2017-05-24 · Aesculap Implant Systems
  Reason: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also…
• GE426R
  FDA Device · Class II · 2017-05-24 · Aesculap Implant Systems
  Reason: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also…
• AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures…
  FDA Device · Class II · 2017-04-19 · Aesculap Implant Systems
  Reason: Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
• GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
  FDA Device · Class II · 2017-02-22 · Aesculap Implant Systems
  Reason: Generators may have a faulty component which could impact the proper functioning of the device.
• Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is inten…
  FDA Device · Class II · 2017-01-11 · Aesculap Implant Systems
  Reason: Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
• Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
  FDA Device · Class II · 2016-11-02 · Aesculap Implant Systems
  Reason: There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.
• Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anter…
  FDA Device · Class II · 2012-09-19 · Aesculap Implant Systems
  Reason: There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert pre…
• Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant S…
  FDA Device · Class II · 2012-08-08 · Aesculap Implant Systems
  Reason: The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with th…
• S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical scr…
  FDA Device · Class II · 2012-07-11 · Aesculap Implant Systems
  Reason: Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw proper…
• Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for…
  FDA Device · Class II · 2012-06-20 · Aesculap Implant Systems
  Reason: During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.