The Recall Desk

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.

26–50 of 61

  • HighFDA (Devices)·Z-2515-2021·2021-09-29

    Univation X System Knee Implant Devices Recalled for Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices because they may loosen, potentially requiring revision surgery. All lots distributed in the US are affected.

    Product
    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 AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2021·2021-09-29

    Univation X System Tray knee implants recalled for loosening defect

    Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.

    Product
    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 univation XF OPT ST0544
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2021·2021-09-29

    Univation X knee implant devices recalled for potential loosening

    Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.

    Product
    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 M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2021·2021-09-29

    Aesculap Univation X System knee implant devices recalled for potential loosening

    Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.

    Product
    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 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F ME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2021·2021-09-29

    Univation X Knee Implant Devices Recalled for Risk of Loosening

    Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could require revision surgery.

    Product
    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 NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2021·2021-09-29

    Univation X Knee Implant Devices Recalled Due to Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.

    Product
    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; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2021·2021-09-29

    Univation X System knee implants recalled for loosening risk

    Aesculap Implant Systems is recalling Univation X System knee implants because they may loosen, potentially requiring additional surgery. The recall affects devices distributed nationwide.

    Product
    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 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F ME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2021·2021-09-29

    Univation X System Knee Implants Recalled for Loosening Risk

    Aesculap Implant Systems recalls Univation X System knee implants nationwide due to risk of loosening that could require revision surgery. All lots are affected.

    Product
    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 AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.

    Product
    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 group of knee endoprosthetics. For these implant parts there a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2020·2020-03-25

    Aesculap Recalls Knee Implants Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low density polyethylene particles may be present on the surface.

    Product
    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 NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2020·2020-03-25

    Aesculap Columbus Knee Implant Components Recalled for LDPE Particles

    Aesculap is recalling Columbus R/PS Tibia Plateau knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.

    Product
    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 implants in the group of knee endoprosthetics. For these impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2020·2020-03-25

    Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    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 NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Pl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2019·2019-09-18

    Aesculap Caiman Disposable Surgical Instrument Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility that the sterility batch was insufficiently sterilized.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2019·2019-09-18

    Aesculap Caiman Disposable Surgical Instruments Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1358-2018·2018-04-18

    Aesculap Recalls Doyen-Collin Mouth Gags Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Doyen-Collin Mouth Gags because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Doyen-Collin Mouth Gag 120MM/ General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1359-2018·2018-04-18

    Aesculap Strauss Penis Clamp Recalled Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Strauss Penis Clamps because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Strauss Penis Clamp 130MM/General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2018·2018-04-11

    Aesculap Recalls DS Titanium Ligation Clip Appliers for Labeling Updates

    Aesculap Implant Systems LLC is recalling 270 DS Titanium Ligation Clip Appliers to update instructions for use, adding contraindications for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1290-2018·2018-04-11

    Aesculap DS Titanium Ligation Clips Recalled for Contraindication Update

    Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0809-2018·2018-03-07

    Aesculap proSA Tool Set Recalled for Incorrect Valve Pressure Adjustment

    Aesculap Implant Systems LLC is recalling proSA Tool Sets because the adjusting pin does not set the correct valve opening pressure for the shunt system.

    Product
    proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0591-2018·2018-02-21

    Aesculap Vega Knee Trial Plateau Recalled for Incorrect Labeling

    Aesculap is recalling 13 units of the NS357R Vega PS Tibia Trial/Preparation Plateau size T4 due to incorrect labeling. Using the wrong size could lead to implantation errors, ligament injury, pain, or revision surgery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2018·2018-02-21

    Aesculap ELAN 4 Air System Recalled for Premarket Clearance Issues

    Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0621-2018·2018-02-21

    Aesculap ELAN 4 Burr and Blade Accessories Recalled for Regulatory Violation

    Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories because they were marketed without 510(k) premarket notification clearance.

    Product
    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 CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0619-2018·2018-02-21

    Aesculap ELAN 4 Burr Accessories Recalled for Lack of FDA Clearance

    Aesculap Implant Systems LLC is recalling ELAN 4 Burr accessories because they were marketed without 510(k) premarket notification clearance.

    Product
    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
    Category
    Medical Device
    Distribution
    4 states