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Aesculap Implant Systems Recalls
62 recalls on record · June 20, 2012 to September 13, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; N
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; N
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
September 29, 2021Medical DevicesFDA
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; N
Hazard: Malfunction- loosening of the implant resulting in a potential revision surgery
March 25, 2020Medical DevicesFDA
Aesculap Implant Systems LLC recalls COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z
Hazard: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
March 25, 2020Medical DevicesFDA
Aesculap Implant Systems LLC recalls AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z
Hazard: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
March 25, 2020Medical DevicesFDA
Aesculap Implant Systems LLC recalls COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K
Hazard: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
March 25, 2020Medical DevicesFDA
Aesculap Implant Systems LLC recalls COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K
Hazard: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
March 25, 2020Medical DevicesFDA
Aesculap Implant Systems LLC recalls Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K N
Hazard: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
September 18, 2019Medical DevicesFDA
Aesculap Implant Systems LLC recalls CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and
Hazard: possibility of the sterility batch being insufficiently sterilized
September 18, 2019Medical DevicesFDA
Aesculap Implant Systems LLC recalls CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and
Hazard: possibility of the sterility batch being insufficiently sterilized
April 18, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls Strauss Penis Clamp 130MM/General Instruments
Hazard: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
April 18, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls Doyen-Collin Mouth Gag 120MM/ General Instruments
Hazard: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
April 11, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Hazard: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
April 11, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip, used in laparoscopic surgery
Hazard: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.
March 7, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and componen
Hazard: A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
February 21, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls JS Series SterilContainer S2 System
Hazard: The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.
February 21, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, an
Hazard: The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
February 21, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls 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.
Hazard: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
February 21, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN
Hazard: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
February 21, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RIN
Hazard: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
February 21, 2018Medical DevicesFDA
Aesculap Implant Systems LLC recalls NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected p
Hazard: The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
May 24, 2017Medical DevicesFDA
Aesculap Implant Systems LLC recalls GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE
Hazard: 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 lead to mechanically induced soft tissue damage.
May 24, 2017Medical DevicesFDA
Aesculap Implant Systems LLC recalls GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-R
Hazard: 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 lead to mechanically induced soft tissue damage.
May 24, 2017Medical DevicesFDA
Aesculap Implant Systems LLC recalls GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1
Hazard: 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 lead to mechanically induced soft tissue damage.
April 19, 2017Medical DevicesFDA
Aesculap Implant Systems LLC recalls AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is fo
Hazard: 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.
February 22, 2017Medical DevicesFDA
Aesculap Implant Systems LLC recalls GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Hazard: Generators may have a faulty component which could impact the proper functioning of the device.
January 11, 2017Medical DevicesFDA
Aesculap Implant Systems LLC recalls Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The
Hazard: Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
November 2, 2016Medical DevicesFDA
Aesculap Implant Systems LLC recalls Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Hazard: 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.
September 19, 2012Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System
Hazard: 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 preventing the screw head from locking down to the bone screw.
August 8, 2012Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage:
Hazard: 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 the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree tria