PlainRecalls

Aesculap Implant Systems LLC

Compiled from official public sources by the editorial team.

61 recalls on record · Latest: Sep 13, 2023

Aesculap Implant Systems LLC Recall Insight

Aesculap Implant Systems LLC appears on 61 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.060% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Sep 13, 2023, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 48 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 36 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 21, 2018 to Sep 13, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Sep 13, 2023

For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

FDA Devices Moderate Jul 26, 2023

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

FDA Devices Moderate May 17, 2023

Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (includ…

FDA Devices Moderate May 3, 2023

Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a contain…

FDA Devices Moderate Sep 7, 2022

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral sp…

FDA Devices Moderate Aug 17, 2022

Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

FDA Devices Moderate Aug 10, 2022

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

FDA Devices Moderate Aug 10, 2022

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

FDA Devices Moderate Jul 27, 2022

AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.

FDA Devices Moderate Jul 27, 2022

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

FDA Devices Moderate Jul 27, 2022

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

FDA Devices Moderate Jul 27, 2022

AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.

FDA Devices Moderate Jul 27, 2022

RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

FDA Devices Moderate Jul 27, 2022

AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.

FDA Devices Moderate Jul 27, 2022

AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.

FDA Devices Moderate Jul 27, 2022

Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

FDA Devices Moderate Jul 27, 2022

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

FDA Devices Moderate Jul 27, 2022

LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.

FDA Devices Moderate Jul 27, 2022

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

FDA Devices Moderate Jul 27, 2022

AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.

FDA Devices Moderate Jul 27, 2022

AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.

FDA Devices Moderate Jul 27, 2022

Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

FDA Devices Moderate Jul 20, 2022

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

FDA Devices Moderate Oct 6, 2021

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

FDA Devices Moderate Oct 6, 2021

PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COM…

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA …

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL C…

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR …

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COM…

FDA Devices Moderate Sep 29, 2021

Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R +…

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL CO…

FDA Devices Moderate Sep 29, 2021

Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COM…

FDA Devices Moderate Mar 25, 2020

Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K…

FDA Devices Moderate Mar 25, 2020

COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476…

FDA Devices Moderate Mar 25, 2020

COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088…

FDA Devices Moderate Mar 25, 2020

AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN07…

FDA Devices Moderate Mar 25, 2020

COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR0…

FDA Devices Moderate Sep 18, 2019

CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where…

FDA Devices Moderate Sep 18, 2019

CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where …

FDA Devices Low Apr 18, 2018

Strauss Penis Clamp 130MM/General Instruments

FDA Devices Low Apr 18, 2018

Doyen-Collin Mouth Gag 120MM/ General Instruments

FDA Devices Moderate Apr 11, 2018

DS Titanium Ligation Clip, used in laparoscopic surgery

FDA Devices Moderate Apr 11, 2018

DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

FDA Devices Moderate Mar 7, 2018

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components

FDA Devices Moderate Feb 21, 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…

FDA Devices Moderate Feb 21, 2018

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 …

FDA Devices Moderate Feb 21, 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.

FDA Devices Moderate Feb 21, 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 K…

FDA Devices Moderate Feb 21, 2018

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,…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Aesculap Implant Systems LLC with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.