Aesculap Implant Systems LLC recalls

58 recalls on record · latest: July 20, 2023

Official U.S. recall history for Aesculap Implant Systems LLC, compiled from official government records.

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Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

July 20, 2023 · Medical device recalls Moderate risk Trocar manufactured with the shaft too long and does not meet manufacturing spe…

Aesculap Surgical Needle recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Incorrect product code marked on the product, etched with product code MD611, h…

Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablat…

March 21, 2023 · Medical device recalls Moderate risk Potential for the spring to become loose and fall out of the device, if the spr…

Aesculap Implant Systems product recalled over labeling errors

February 23, 2023 · Medical device recalls Moderate risk Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct G…

Aesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the…

July 15, 2022 · Medical device recalls Moderate risk Potential for the incorrect screw to be included in the package.

Aesculap Implant Systems LLC recalls Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

July 14, 2022 · Medical device recalls Moderate risk Application error problems: Rebalance scope message: 1.Rebalancing process 2.Us…

Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

October 25, 2021 · Medical device recalls Moderate risk Set screwdriver fails during surgery by deforming at the tip during engagement…

Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

June 30, 2021 · Medical device recalls Moderate risk Customized coronal rod benders may deform the implant when used with the spinal…

Aesculap Implant Systems LLC recalls LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.

June 30, 2021 · Medical device recalls Moderate risk Customized coronal rod benders may deform the implant when used with the spinal…

Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

April 16, 2021 · Medical device recalls Moderate risk Malfuncton-Implant did not deploy successfully may necessitate the need for an…

Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

April 16, 2021 · Medical device recalls Moderate risk Malfuncton-Implant did not deploy successfully may necessitate the need for an…

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL47…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems product recalled over E. coli risk

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL4…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL47…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set S…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL4…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL48…

March 19, 2021 · Medical device recalls Moderate risk Malfunction- loosening of the implant resulting in a potential revision surgery

Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

February 19, 2021 · Medical device recalls Moderate risk Malfunction of the robotic arm preventing further movement of the robotic arm a…

Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

November 18, 2020 · Medical device recalls Moderate risk Fracture or breakage of the spinal fixation arm at the downtube instrument if t…

Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion…

September 8, 2020 · Medical device recalls Moderate risk Insufficient clamping force of the cross connectors in the spinal surgical syst…

Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spin…

September 8, 2020 · Medical device recalls Moderate risk Insufficient clamping force of the cross connectors in the spinal surgical syst…

Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spin…

September 8, 2020 · Medical device recalls Moderate risk Insufficient clamping force of the cross connectors in the spinal surgical syst…

Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion sur…

September 8, 2020 · Medical device recalls Moderate risk Insufficient clamping force of the cross connectors in the spinal surgical syst…

Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion…

September 8, 2020 · Medical device recalls Moderate risk Insufficient clamping force of the cross connectors in the spinal surgical syst…

Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion…

September 8, 2020 · Medical device recalls Moderate risk Insufficient clamping force of the cross connectors in the spinal surgical syst…

Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

July 13, 2020 · Medical device recalls Moderate risk Fracture or breakage of the spinal fixation arm at the downtube instrument if t…

Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

April 1, 2020 · Medical device recalls Moderate risk Endoscopic graspers may become separated at the weld from handle to the shaft o…

Aesculap Implant Systems LLC recalls PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

April 1, 2020 · Medical device recalls Moderate risk Endoscopic graspers may become separated at the weld from handle to the shaft o…

Aesculap Implant Systems LLC recalls Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN07…

January 21, 2020 · Medical device recalls Moderate risk Low Density Polyethylene (LDPE) particles may be present on the surface of the…

Aesculap Implant Systems LLC recalls COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN47…

January 21, 2020 · Medical device recalls Moderate risk Low Density Polyethylene (LDPE) particles may be present on the surface of the…

Aesculap Implant Systems LLC recalls COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN08…

January 21, 2020 · Medical device recalls Moderate risk Low Density Polyethylene (LDPE) particles may be present on the surface of the…

Aesculap Implant Systems LLC recalls AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN07…

January 21, 2020 · Medical device recalls Moderate risk Low Density Polyethylene (LDPE) particles may be present on the surface of the…

Aesculap Implant Systems LLC recalls COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR…

January 21, 2020 · Medical device recalls Moderate risk Low Density Polyethylene (LDPE) particles may be present on the surface of the…

Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during…

November 12, 2019 · Medical device recalls Moderate risk Nonfunctional key due to the potential for damage to the key pins cause by forc…

Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, prod…

October 1, 2019 · Medical device recalls Moderate risk Packaging seal integrity not validated resulting in a lack of sterility assuran…

Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a su…

September 25, 2019 · Medical device recalls Moderate risk Needleholder incorrectly labeled as 200MM when the actual instrument size is 15…

Aesculap Implant Systems LLC recalls CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and…

August 7, 2019 · Medical device recalls Moderate risk possibility of the sterility batch being insufficiently sterilized

Aesculap Implant Systems LLC recalls CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and…

August 7, 2019 · Medical device recalls Moderate risk possibility of the sterility batch being insufficiently sterilized

Aesculap Implant Systems LLC recalls Strauss Penis Clamp 130MM/General Instruments

February 16, 2018 · Medical device recalls The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during…

Aesculap Implant Systems LLC recalls Doyen-Collin Mouth Gag 120MM/ General Instruments

February 16, 2018 · Medical device recalls The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during…

Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip, used in laparoscopic surgery

January 22, 2018 · Medical device recalls Moderate risk Added a contraindication to IFU: Do not use the DS clips for living donor nephr…

Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

January 22, 2018 · Medical device recalls Moderate risk Added a contraindication to IFU: Do not use the DS clips for living donor nephr…

Aesculap Implant Systems LLC recalls proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components

September 21, 2017 · Medical device recalls Moderate risk A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not…

Aesculap Implant Systems LLC recalls JS Series SterilContainer S2 System

September 8, 2017 · Medical device recalls Moderate risk The JS Series SterilContainer S2 System was released to the market place prior…

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 D2.0…

September 5, 2017 · Medical device recalls Moderate risk ELAN 4 burr/blade accessories were marketed without 510(k) premarket notificati…

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-RING…

September 5, 2017 · Medical device recalls Moderate risk ELAN 4 burr/blade accessories were marketed without 510(k) premarket notificati…

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 4…

September 5, 2017 · Medical device recalls Moderate risk ELAN 4 burr/blade accessories were marketed without 510(k) premarket notificati…

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, a…

September 1, 2017 · Medical device recalls Moderate risk The ELAN 4 Air System was released to the market place prior to an authorized F…

Aesculap Implant Systems LLC recalls NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected par…

August 10, 2017 · Medical device recalls Moderate risk The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly l…

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 XS D…

March 28, 2017 · Medical device recalls Moderate risk Diamond particulates may break off the burr and fall into the surgical site. If…

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-RING D…

March 28, 2017 · Medical device recalls Moderate risk Diamond particulates may break off the burr and fall into the surgical site. If…

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-RING…

March 28, 2017 · Medical device recalls Moderate risk Diamond particulates may break off the burr and fall into the surgical site. If…

AESCULAP MINOP InVent 30 Trocar System recalled over laceration hazard

March 7, 2017 · Medical device recalls Moderate risk Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibili…

Aesculap Implant Systems LLC recalls GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

January 9, 2017 · Medical device recalls Moderate risk Generators may have a faulty component which could impact the proper functionin…

Aesculap Implant Systems product recalled over sterility concerns

October 28, 2016 · Medical device recalls Moderate risk Aesculap has received complaints of excessive bleeding after use of Gomco Circu…

Aesculap Implant Systems LLC recalls Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

August 1, 2016 · Medical device recalls Moderate risk There is a potential for the needle to detach from the suture thread during sur…