Aesculap Implant Systems LLC

Medical device manufacturer in Center Valley, PA.

51510(k) clearances
0PMA approvals
73recalls

Device types

510(k) clearances

510(k)DeviceDecision
K213871Ennovate Cervical Spinal and Occiput SystemNKG · Traditional 07/01/2022SE
K210963ENNOVATE Spinal SystemNKB · Traditional 07/19/2021SE
K180433Ennovate®NKB · Traditional 04/26/2018SE
K162134ENNOVATE Spinal SystemNKB · Traditional 12/14/2016SE
K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsOLO · Traditional 07/08/2016SE
K153629ArcadiusXP C Spinal SystemOVE · Traditional 05/25/2016SE
K153396Aesculap OrthoPilot Next GenerationOLO · Traditional 05/16/2016SE
K151938S4 Cervical Spinal and Occiput SystemsNKG · Traditional 10/21/2015SE
K151056Aesculap T-Space PEEK and XP Spinal SystemMAX · Traditional 08/13/2015SE
K150544Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemJWH · Special 05/29/2015SE
K141694Aesculap Orthopilot Next GenerationOLO · Special 02/24/2015SE
K150062Excia Total Hip SystemLZO · Special 02/09/2015SE
K143106VEGA Knee SystemJWH · Special 11/21/2014SE
K140915Excia Total Hip SystemLZO · Special 07/21/2014SE
K140452Vega Knee SystemJWH · Special 03/25/2014SE
K132421Aesculap PEEK XP Spinal Implant SystemMAX · Traditional 01/22/2014SE
K131167UnivationHRY · Traditional 10/17/2013SE
K123939S4 Spinal SystemNKB · Traditional 03/12/2013SE
K120955Columbus Total Knee System AS Columbus Revision Knee System Enduro Knee SystemJWH · Traditional 12/17/2012SE
K123352S4 Spinal SystemNKB · Traditional 12/12/2012SE
K121801Quintex Cervical Plating SystemKWQ · Traditional 09/11/2012SE
K121879Vega Knee SystemJWH · Special 07/27/2012SE
K112682Metha Hip SystemLZO · Traditional 03/19/2012SE
K111122Aesculap Sibd XP Spinal SystemOVD · Traditional 08/04/2011SE
K110864Biospine VBR SystemMQP · Traditional 06/15/2011SE
K102057Targon FN SystemKTT · Traditional 12/21/2010SE
K101815Enduro Knee SystemKRO · Traditional 12/20/2010SE
K102424Prevision Hip System with Recon RingMEH · Traditional 12/09/2010SE
K103284Laminoplasy Plating SystemNQW · Special 12/02/2010SE
K102505Hto Plating SystemHRS · Special 11/24/2010SE
K100243Quintex Cervical Plating SystemKWQ · Traditional 09/02/2010SE
K100802Aesculap Implant Systems Sibd Spinal SystemOVD · Traditional 07/20/2010SE
K100623Aesculap Implant Systems S4 Spinal SystemNKB · Traditional 06/09/2010SE
K092143Excia Total Hip System M an ML Femoral StemMEH · Special 09/22/2009SE
K083004Mili (Minimally Invasive Lumbar Implant) SystemNKB · Traditional 07/02/2009SE
K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsLZO · Special 04/24/2009SE
K090657Modification to: S4 Spinal SystemNKB · Special 04/20/2009SE
K083311Aesculap Cespace PEEK Intervertebral Body Fusion SystemODP · Traditional 03/04/2009SE
K083495Modification to: Metha Hip SystemLZO · Special 01/15/2009SE
K082991Biolox Delta Ceramic Femoral HeadLZO · Special 11/20/2008SE
K081293Univation Unicondylar Knee SystemHRY · Traditional 09/22/2008SE
K082146Metha Short Stem Hip System XL Femoral HeadLWJ · Special 09/09/2008SE
K080992Aesculap Implant Systems High Tibial Osteotomy Plating SystemHRS · Traditional 09/04/2008SE
K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemLZO · Special 08/07/2008SE
K071916Metha Hip SystemMEH · Traditional 06/02/2008SE
K071983Aesculap PEEK Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceMAX · Traditional 05/01/2008SE
K072899Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0HAW · Special 02/06/2008SE
K071945S4 Spinal SystemNKB · Special 09/20/2007SE
K071499Columbus Total Knee System Mios Cr/Ps Tibial TrayJWH · Traditional 09/14/2007SE
K070981Search Evolution (LC) Total Knee System (Plasmapore)JWH · Traditional 08/21/2007SE
K071220Columbus Total Knee System ASJWH · Special 06/01/2007SE

Recalls

RecallProductInitiated
Z-2518-2023 Class IIFor intraventricular indications mainly used for operations within the brain ventricles.…Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result… 07/20/2023Open, Classified
Z-2146-2023 Class IIAesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile…Incorrect product code marked on the product, etched with product code MD611, however; the correct product… 05/18/2023Open, Classified
Z-1569-2023 Class IIAesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation…Potential for the spring to become loose and fall out of the device, if the spring falls out during a… 03/21/2023Open, Classified
Z-1430-2023 Class IICaspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical…Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. 02/23/2023Open, Classified
Z-1638-2022 Class IIAesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and…Potential for the incorrect screw to be included in the package. 07/15/2022Open, Classified
Z-1516-2022 Class IIAeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number:…Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3.… 07/14/2022Terminated
Z-1410-2022 Class IIMODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument…Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the… 10/25/2021Terminated
Z-1406-2022 Class IILEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.Customized coronal rod benders may deform the implant when used with the spinal system devices. 06/30/2021Terminated
Z-1405-2022 Class IIRIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.Customized coronal rod benders may deform the implant when used with the spinal system devices. 06/30/2021Terminated
Z-2579-2021 Class IIPAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical… 04/16/2021Terminated
Z-2578-2021 Class IIPAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUMalfuncton-Implant did not deploy successfully may necessitate the need for an additional medical… 04/16/2021Terminated
Z-2516-2021 Class IIUnivation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2515-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2514-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2513-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2512-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2511-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2510-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-2509-2021 Class IIUnivation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F…Malfunction- loosening of the implant resulting in a potential revision surgery 03/19/2021Terminated
Z-1409-2022 Class IIUniversal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope…Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the… 02/19/2021Completed
Z-1429-2022 Class IIENNOVATE MIS REMOVALKEY SHORT, product code SZ380RFracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met… 11/18/2020Terminated
Z-1448-2022 Class IIAESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… 09/08/2020Terminated
Z-1447-2022 Class IIAESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… 09/08/2020Terminated
Z-1446-2022 Class IIAESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… 09/08/2020Terminated
Z-1445-2022 Class IIAESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… 09/08/2020Terminated
Z-1444-2022 Class IIAESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… 09/08/2020Terminated
Z-1443-2022 Class IIAESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… 09/08/2020Terminated
Z-1428-2022 Class IIENNOVATE MIS REMOVALKEY SHORT, product code SZ380RFracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met… 07/13/2020Terminated
Z-1482-2022 Class IIPRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH.…Endoscopic graspers may become separated at the weld from handle to the shaft of the device. 04/01/2020Completed
Z-1481-2022 Class IIPRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product…Endoscopic graspers may become separated at the weld from handle to the shaft of the device. 04/01/2020Completed
Z-1482-2020 Class IICOLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.…Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of… 01/21/2020Terminated
Z-1481-2020 Class IIAS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos.…Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of… 01/21/2020Terminated
Z-1480-2020 Class IICOLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos.…Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of… 01/21/2020Terminated
Z-1479-2020 Class IICOLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos.…Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of… 01/21/2020Terminated
Z-1478-2020 Class IIColumbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos.…Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of… 01/21/2020Terminated
Z-1391-2022 Class IIENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee…Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of… 11/12/2019Completed
Z-1449-2022 Class IIAesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50…Packaging seal integrity not validated resulting in a lack of sterility assurance. 10/01/2019Terminated
Z-1383-2022 Class IIAESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical…Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. 09/25/2019Terminated
Z-2497-2019 Class IICAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended…possibility of the sterility batch being insufficiently sterilized 08/07/2019Terminated
Z-2496-2019 Class IICAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended…possibility of the sterility batch being insufficiently sterilized 08/07/2019Terminated
Z-1359-2018 Class IIIStrauss Penis Clamp 130MM/General InstrumentsThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing… 02/16/2018Terminated
Z-1358-2018 Class IIIDoyen-Collin Mouth Gag 120MM/ General InstrumentsThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing… 02/16/2018Terminated
Z-1291-2018 Class IIDS Titanium Ligation Clip Appliers, used in laparoscopic surgeryAdded a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other… 01/22/2018Terminated
Z-1290-2018 Class IIDS Titanium Ligation Clip, used in laparoscopic surgeryAdded a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other… 01/22/2018Terminated
Z-0809-2018 Class IIproSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt…A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve… 09/21/2017Terminated
Z-0624-2018 Class IIJS Series SterilContainer S2 SystemThe JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K… 09/08/2017Terminated
Z-0621-2018 Class IIELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4…ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. 09/05/2017Terminated
Z-0620-2018 Class IIELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4…ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. 09/05/2017Terminated
Z-0619-2018 Class IIELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING…ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. 09/05/2017Terminated
Z-0623-2018 Class IIThe ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in…The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue… 09/01/2017Terminated
Z-0591-2018 Class IINS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee…The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size… 08/10/2017Terminated
Z-2089-2017 Class IIGE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… 03/28/2017Terminated
Z-2088-2017 Class IIGP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… 03/28/2017Terminated
Z-2087-2017 Class IIGP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… 03/28/2017Terminated
Z-1814-2017 Class IIAESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent…Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on… 03/07/2017Terminated
Z-1218-2017 Class IIGN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessoriesGenerators may have a faulty component which could impact the proper functioning of the device. 01/09/2017Terminated
Z-0947-2017 Class IIGomco Circumcision Clamps with separate O-Ring Component: The device is packaged…Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. 10/28/2016Terminated
Z-0316-2017 Class IISafil QUI + UNDY 5/0 (1) 45CM DSMP13 SutureThere is a potential for the needle to detach from the suture thread during surgery. If the needle becomes… 08/01/2016Terminated
Z-2333-2012 Class IIAesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and…There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the… 07/25/2012Terminated
Z-2114-2012 Class IIAesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial…The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part… 07/12/2012Terminated
Z-1934-2012 Class IIS4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments…Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision… 03/07/2012Terminated
Z-1793-2012 Class IIColumbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage -…During an internal quality inspection, the tibia plateau was found to be out of specification. There is a… 02/21/2012Terminated
Z-1455-2012 Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is…The firm has received complaints that the locking ring that sits in the head of the screw can come out of… 01/24/2012Terminated
Z-0445-2008 Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0444-2008 Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0443-2008 Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0442-2008 Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0441-2008 Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0440-2008 Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0439-2008 Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0438-2008 Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0437-2008 Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated
Z-0436-2008 Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment 10/10/2007Terminated