Aesculap Implant Systems LLC

FDA recalling firm · 35 enforcement events · 61 product records · 2012–2023 · PA

Aesculap Implant Systems LLC has 35 FDA enforcement events on this register (61 product records) between 2012 and 2023: 35 device; the busiest year was 2017 with 8.

0% of its events are Class I; the most common class is Class II (34). 5 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
20 Jul 2023	For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R	Device	Class II	1	Ongoing
18 May 2023	Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610	Device	Class II	1	Ongoing
21 Mar 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 intended for open surgery. Product Code: PL771SU	Device	Class II	1	Ongoing
23 Feb 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 medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR…	Device	Class II	1	Ongoing
15 Jul 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	Device	Class II	1	Ongoing
14 Jul 2022	Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010	Device	Class II	1	Terminated
25 Oct 2021	MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441	Device	Class II	1	Terminated
30 Jun 2021	RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.	Device	Class II	2	Terminated
16 Apr 2021	PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU	Device	Class II	2	Terminated
19 Mar 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 F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F…	Device	Class II	8	Terminated
19 Feb 2021	Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010	Device	Class II	1	Completed
18 Nov 2020	ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R	Device	Class II	1	Terminated
8 Sep 2020	AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.	Device	Class II	6	Terminated
13 Jul 2020	ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R	Device	Class II	1	Terminated
1 Apr 2020	PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10	Device	Class II	2	Completed
21 Jan 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 implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free…	Device	Class II	5	Terminated
12 Nov 2019	ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.	Device	Class II	1	Completed
1 Oct 2019	Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.	Device	Class II	1	Terminated
25 Sep 2019	AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle	Device	Class II	1	Terminated
7 Aug 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.	Device	Class II	2	Terminated
16 Feb 2018	Doyen-Collin Mouth Gag 120MM/ General Instruments	Device	Class III	2	Terminated
22 Jan 2018	DS Titanium Ligation Clip, used in laparoscopic surgery	Device	Class II	2	Terminated
21 Sep 2017	proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components	Device	Class II	1	Terminated
8 Sep 2017	JS Series SterilContainer S2 System	Device	Class II	1	Terminated
5 Sep 2017	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 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…	Device	Class II	3	Terminated
1 Sep 2017	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.	Device	Class II	1	Terminated
10 Aug 2017	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 of the diseased knee joint.	Device	Class II	1	Terminated
28 Mar 2017	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 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…	Device	Class II	3	Terminated
7 Mar 2017	AESCULAP 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.	Device	Class II	1	Terminated
9 Jan 2017	GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories	Device	Class II	1	Terminated
28 Oct 2016	Gomco 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 surgeries	Device	Class II	1	Terminated
1 Aug 2016	Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture	Device	Class II	1	Terminated
25 Jul 2012	Aesculap 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…	Device	Class II	1	Terminated
12 Jul 2012	Aesculap 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 patient	Device	Class II	1	Terminated
7 Mar 2012	S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.	Device	Class II	1	Terminated

By type and class

Device35

Class II34

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Aesculap Implant Systems LLC by year initiated.

Questions and answers

How many FDA recalls has Aesculap Implant Systems LLC had?

35 enforcement events (61 product records) on this register, 2012–2023: 35 device.

Are any Aesculap Implant Systems LLC recalls ongoing?

5 events are listed as ongoing in the current openFDA export.

What class are Aesculap Implant Systems LLC recalls?

34 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.