The Recall Desk

Manufacturer

TeDan Surgical Innovations LLC

13 recalls in our database name TeDan Surgical Innovations LLC as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
1
Most recent
2020-07-15

Of the 13 recalls from TeDan Surgical Innovations 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 (8%) 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.

1–13 of 13

  • HighFDA (Devices)·Z-2527-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal

    TeDan Surgical Innovations is recalling 1,965 sterile Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile claim.

    Product
    PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal

    TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.

    Product
    PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2020·2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 340 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect

    TeDan Surgical Innovations LLC is recalling 495 Phantom CS Quick Start Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2020·2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 730 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2525-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because the sterile pouch seal is defective, potentially compromising sterility.

    Product
    3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2020·2020-05-13

    TeDan Recalls Fukushima Suction Tubes Due to Incorrect Raw Material

    TeDan Surgical Innovations LLC is recalling Fukushima suction tubes because incorrect raw material was used in production. The affected units were distributed in New Jersey.

    Product
    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1506-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.

    Product
    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1504-2020·2020-03-25

    TeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by tra
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1505-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns

    TeDan Surgical Innovations is recalling Quick Start Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing a risk of infection.

    Product
    DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1503-2020·2020-03-25

    TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by tra
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2385-2012·2012-09-26

    Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws

    Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.

    Product
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Sc
    Category
    Medical Device
    Distribution
    Distributed nationwide