Recall Register

Aesculap Implant Systems LLC: FDA recalls

FDA enforcement events from 2012 to 2023; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Aesculap Implant Systems LLC as the recalling firm in 35 events. The events have 61 product records. The recalls started from 2012 to 2023. All the events are device recalls. By FDA enforcement events, Aesculap Implant Systems LLC is number 92 of 1,628 firms that have a page. Events that Aesculap Implant Systems LLC started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 97.1% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

35 events, newest first.

FDA enforcement events of Aesculap Implant Systems LLC
InitiatedProduct (first record)TypeClassRecordsStatus
20 Jul 2023For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399RDeviceClass II1Ongoing
18 May 2023Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610DeviceClass II1Ongoing
21 Mar 2023Aesculap 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 intended for open surgery. Product Code: PL771SUDeviceClass II1Ongoing
23 Feb 2023Caspar 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 medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR…DeviceClass II1Ongoing
15 Jul 2022Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014DeviceClass II1Ongoing
14 Jul 2022Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010DeviceClass II1Terminated
25 Oct 2021MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441DeviceClass II1Terminated
30 Jun 2021RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.DeviceClass II2Terminated
16 Apr 2021PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUDeviceClass II2Terminated
19 Mar 2021Univation 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 F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F…DeviceClass II8Terminated
19 Feb 2021Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010DeviceClass II1Completed
18 Nov 2020ENNOVATE MIS REMOVALKEY SHORT, product code SZ380RDeviceClass II1Terminated
8 Sep 2020AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.DeviceClass II6Terminated
13 Jul 2020ENNOVATE MIS REMOVALKEY SHORT, product code SZ380RDeviceClass II1Terminated
1 Apr 2020PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10DeviceClass II2Completed
21 Jan 2020Columbus 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 implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free…DeviceClass II5Terminated
12 Nov 2019ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.DeviceClass II1Completed
1 Oct 2019Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.DeviceClass II1Terminated
25 Sep 2019AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needleDeviceClass II1Terminated
7 Aug 2019CAIMAN 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.DeviceClass II2Terminated
16 Feb 2018Doyen-Collin Mouth Gag 120MM/ General InstrumentsDeviceClass III2Terminated
22 Jan 2018DS Titanium Ligation Clip, used in laparoscopic surgeryDeviceClass II2Terminated
21 Sep 2017proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and componentsDeviceClass II1Terminated
8 Sep 2017JS Series SterilContainer S2 SystemDeviceClass II1Terminated
5 Sep 2017ELAN 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 ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC…DeviceClass II3Terminated
1 Sep 2017The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.DeviceClass II1Terminated
10 Aug 2017NS357R 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 of the diseased knee joint.DeviceClass II1Terminated
28 Mar 2017GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; GP167R; ELAN 4 1-RING…DeviceClass II3Terminated
7 Mar 2017AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.DeviceClass II1Terminated
9 Jan 2017GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessoriesDeviceClass II1Terminated
28 Oct 2016Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeriesDeviceClass II1Terminated
1 Aug 2016Safil QUI + UNDY 5/0 (1) 45CM DSMP13 SutureDeviceClass II1Terminated
25 Jul 2012Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to…DeviceClass II1Terminated
12 Jul 2012Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patientDeviceClass II1Terminated
7 Mar 2012S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Aesculap Implant Systems LLC: events for each product type
TypeEvents
Device35
Aesculap Implant Systems LLC: events in each class
ClassEvents
Class II34
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Aesculap Implant Systems LLC, by the year that the recall started. The largest year is 2017, with 8 events.

Official channels

Cite this page

Recall Register. Aesculap Implant Systems LLC: FDA recalls. https://recallregister.com/firm/aesculap-implant-systems-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
PA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Aesculap Implant Systems LLC have?
Class II: 34 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Aesculap Implant Systems LLC?
FDA event 92813, which the firm started on 20 Jul 2023. The first product in the record is: For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
How many FDA recalls of Aesculap Implant Systems LLC have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.