Manufacturer

Aesculap Implant Systems LLC

61 recalls in our database name Aesculap Implant Systems LLC as the manufacturing or recalling firm.

What the numbers show

Total: 61
Critical: 0
Severe: 1
Most recent: 2023-09-13

Of the 61 recalls from Aesculap Implant Systems LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–61 of 61

ModerateFDA (Devices)·Z-0620-2018·2018-02-21
Aesculap ELAN 4 Drill Accessories Recalled for Lack of FDA Clearance
Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.
Product
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 D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIS
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2087-2017·2017-05-24
Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage
Aesculap Implant Systems LLC is recalling 608 ELAN 4 diamond burrs because particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2088-2017·2017-05-24
Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage Risk
Aesculap Implant Systems LLC is recalling ELAN 4 2-Ring Diamond Burrs because diamond particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.
Product
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 DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2017·2017-05-24
Aesculap Hi-Line XS Diamond Burrs Recalled for Particulate Breakage Risk
Aesculap Implant Systems LLC is recalling 608 Hi-Line XS Diamond Burrs because diamond particulates may break off and fall into the surgical site, potentially causing foreign body reactions or soft tissue damage.
Product
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 DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1814-2017·2017-04-19
Aesculap Minop InVent 30 Trocar System Recalled for Sharp Edges
Aesculap Implant Systems LLC is recalling the Minop InVent 30 Trocar System because sharp edges may abrade insulation during use.
Product
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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1218-2017·2017-02-22
Aesculap GN200 Caiman HF Generators Recalled for Faulty Component
Aesculap Implant Systems LLC is recalling 24 GN200 Caiman HF generators due to a faulty component that may impact proper device functioning.
Product
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2017·2017-01-11
Aesculap Recalls Gomco Circumcision Clamps Due to Excessive Bleeding Reports
Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps nationwide after receiving complaints of excessive bleeding following use.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0316-2017·2016-11-02
Aesculap Safil Suture Recall Due to Needle Detachment Risk
Aesculap is recalling 180 units of Safil QUI + UNDY 5/0 sutures because the needle may detach from the thread during surgery.
Product
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2333-2012·2012-09-19
Aesculap S4 Polyaxial Screws Recalled for Potential Channel Tolerance Defect
Aesculap Implant Systems LLC is recalling S4 Element 4.5mm Polyaxial Screws because the screw channel may be out of tolerance, potentially preventing the screw head from locking to the bone.
Product
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 i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2114-2012·2012-08-08
Aesculap SIBD Trial Implants Recalled for Incorrect Part Number Etching
Aesculap Implant Systems LLC is recalling 5 SIBD trial implants because the part numbers etched on the instruments may be incorrect, potentially causing selection errors.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1934-2012·2012-07-11
Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues
Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.
Product
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Category
Medical Device
Distribution
Distributed nationwide