Center Valley, PA, United States
Aesculap Implant Systems LLC recalls
27 recalls recorded since 2018, most recently on 20 July 2023. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls27
Ongoing (FDA)5
Terminated or completed22
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 July 2023
- Reason
- Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2518-2023
- For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Ongoing Class II Medical devices
- Recall started
- 18 May 2023
- Reason
- Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
- Distribution
- US Nationwide distribution in the states of DC, MO, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2146-2023
- Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Ongoing Class II Medical devices
- Recall started
- 21 March 2023
- Reason
- Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
- Distribution
- US Nationwide distribution in the state of OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1569-2023
- Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intende
Ongoing Class II Medical devices
- Recall started
- 23 February 2023
- Reason
- Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
- Distribution
- US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1430-2023
- Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many
Ongoing Class II Medical devices
- Recall started
- 15 July 2022
- Reason
- Potential for the incorrect screw to be included in the package.
- Distribution
- GA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1638-2022
- Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Terminated Class II Medical devices
- Recall started
- 14 July 2022
- Terminated
- 7 February 2025
- Reason
- Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
- Distribution
- US Distribution to states of: AR, IN, NE and NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1516-2022
- Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Terminated Class II Medical devices
- Recall started
- 25 October 2021
- Terminated
- 12 June 2024
- Reason
- Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
- Distribution
- US: CA, FL, GA, IL, OH & MI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1410-2022
- MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Terminated Class II Medical devices
- Recall started
- 30 June 2021
- Terminated
- 17 April 2024
- Reason
- Customized coronal rod benders may deform the implant when used with the spinal system devices.
- Distribution
- United States: CO
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1405-2022, Z-1406-2022
- RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
- LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Terminated Class II Medical devices
- Recall started
- 16 April 2021
- Terminated
- 18 January 2023
- Reason
- Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
- Distribution
- US Nationwide distribution in the states of FL, MI, NY, TX, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2578-2021, Z-2579-2021
- PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
- PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Terminated Class II Medical devices
- Recall started
- 19 March 2021
- Terminated
- 28 March 2025
- Reason
- Malfunction- loosening of the implant resulting in a potential revision surgery
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2509-2021, Z-2514-2021, Z-2513-2021, Z-2515-2021, Z-2510-2021, Z-2516-2021, Z-2512-2021, Z-2511-2021
- Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473
- Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z
- Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL49
- Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z
- Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 U
- Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univati
- Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL49
- Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 U
Completed Class II Medical devices
- Recall started
- 19 February 2021
- Reason
- Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
- Distribution
- United States: NE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1409-2022
- Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Terminated Class II Medical devices
- Recall started
- 18 November 2020
- Terminated
- 23 December 2024
- Reason
- Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
- Distribution
- United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1429-2022
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Terminated Class II Medical devices
- Recall started
- 8 September 2020
- Terminated
- 10 April 2024
- Reason
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Distribution
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1444-2022, Z-1448-2022, Z-1447-2022, Z-1446-2022, Z-1443-2022, Z-1445-2022
- AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
- AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
- AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
- AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
- AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
- AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Terminated Class II Medical devices
- Recall started
- 13 July 2020
- Terminated
- 26 April 2024
- Reason
- Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
- Distribution
- United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1428-2022
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Completed Class II Medical devices
- Recall started
- 1 April 2020
- Reason
- Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
- Distribution
- United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1482-2022, Z-1481-2022
- PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
- PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Terminated Class II Medical devices
- Recall started
- 21 January 2020
- Terminated
- 22 September 2021
- Reason
- Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1478-2020, Z-1480-2020, Z-1479-2020, Z-1481-2020, Z-1482-2020
- Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of impl
- COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of im
- COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the gr
- AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN4
- COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR
Completed Class II Medical devices
- Recall started
- 12 November 2019
- Reason
- Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1391-2022
- ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Terminated Class II Medical devices
- Recall started
- 1 October 2019
- Terminated
- 6 June 2024
- Reason
- Packaging seal integrity not validated resulting in a lack of sterility assurance.
- Distribution
- United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1449-2022
- Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Terminated Class II Medical devices
- Recall started
- 25 September 2019
- Terminated
- 1 April 2024
- Reason
- Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
- Distribution
- United States: TX and AK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1383-2022
- AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Terminated Class II Medical devices
- Recall started
- 7 August 2019
- Terminated
- 12 May 2020
- Reason
- possibility of the sterility batch being insufficiently sterilized
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2496-2019, Z-2497-2019
- CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
- CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Terminated Class III Medical devices
- Recall started
- 16 February 2018
- Terminated
- 30 June 2020
- Reason
- The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1359-2018, Z-1358-2018
- Strauss Penis Clamp 130MM/General Instruments
- Doyen-Collin Mouth Gag 120MM/ General Instruments
Terminated Class II Medical devices
- Recall started
- 22 January 2018
- Terminated
- 24 September 2019
- Reason
- 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.
- Distribution
- US and Canada distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1290-2018, Z-1291-2018
- DS Titanium Ligation Clip, used in laparoscopic surgery
- DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Terminated Class II Medical devices
- Recall started
- 21 September 2017
- Terminated
- 8 August 2018
- Reason
- A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
- Distribution
- US Distribution to PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0809-2018
- proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Terminated Class II Medical devices
- Recall started
- 8 September 2017
- Terminated
- 4 April 2019
- Reason
- 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.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0624-2018
- JS Series SterilContainer S2 System
Terminated Class II Medical devices
- Recall started
- 5 September 2017
- Terminated
- 20 September 2019
- Reason
- ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
- Distribution
- Distributed to 4 hospitals in the following states: NM, OH, TX, WV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0621-2018, Z-0619-2018, Z-0620-2018
- 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 CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO
- 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 ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING RO
- 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 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1
Terminated Class II Medical devices
- Recall started
- 1 September 2017
- Terminated
- 3 April 2019
- Reason
- 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).
- Distribution
- Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0623-2018
- The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Terminated Class II Medical devices
- Recall started
- 10 August 2017
- Terminated
- 8 August 2018
- Reason
- 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.
- Distribution
- USA (nationwide)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0591-2018
- NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.