The Recall Desk

Manufacturer

Waldemar Link GmbH & Co. KG (Mfg Site)

61 recalls in our database name Waldemar Link GmbH & Co. KG (Mfg Site) as the manufacturing or recalling firm.

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.

1–25 of 61

  • ModerateFDA (Devices)·Z-1651-2026·2026-04-01

    Embrace Drill Tower Shoulder Instruments Recalled for Incorrect Article Numbers

    Waldemar Link is recalling 75 units of the Embrace Shoulder Drill Tower because the surgical technique overview contains incorrect article numbers. The individual surgical steps remain correct despite the documentation error.

    Product
    Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1652-2026·2026-04-01

    Embrace Drill Tower surgical documentation contains mixed-up article numbers

    Waldemar Link is recalling the Embrace Shoulder Instruments Drill Tower due to mixed-up article numbers in the surgical technique overview. The actual surgical steps are correct.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1512-2026·2026-03-18

    Waldemar Link Endo-Model Replacement Plateau Implant Bushing Detachment Risk

    Waldemar Link is recalling Endo-Model Replacement Plateau implants due to risk that the bushing could detach from the screw shaft due to longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2026·2026-03-18

    Endo-Model Replacement Plateau Screw Bushing Could Detach During Use

    Waldemar Link is recalling Endo-Model Replacement Plateau surgical implants due to potential bushing detachment from the screw shaft. The defect could cause implant failure.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2835/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1521-2026·2026-03-18

    Endo-Model Replacement Plateau orthopedic implant: bushing detachment risk

    Waldemar Link is recalling Endo-Model Replacement Plateau implants due to the potential for bushing detachment from the screw shaft caused by longitudinal fracture. Affected units were distributed in the US and worldwide.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2026·2026-03-18

    Orthopedic implant connection component recalled due to potential bushing detachment

    Waldemar Link is recalling Endo-Model SL Connection Component implants due to potential bushing detachment from the plateau screw caused by longitudinal fracture. 44 units affected worldwide.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2026·2026-03-18

    Endo-Model Replacement Plateau implant screw bushing may detach

    The Endo-Model Replacement Plateau implant is being recalled because the screw bushing may detach due to a longitudinal fracture, potentially compromising implant function.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2026·2026-03-18

    Endo-Model SL Implant Connection Component Recalled for Bushing Detachment Risk

    An implant connection component manufactured by Waldemar Link may experience bushing detachment due to a longitudinal screw fracture. The recall affects 31 units distributed in the United States and internationally.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2026·2026-03-18

    Orthopedic Implant Plateau Recalled for Potential Bushing Detachment Risk

    Waldemar Link is recalling Endo-Model Replacement Plateau implants (Item 15-2836/11) due to potential bushing detachment from the screw shaft caused by longitudinal fracture. Seven units affected worldwide including the US. No injuries reported.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2836/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2026·2026-03-18

    Endo-Model plateau screw implants recalled due to potential bushing failure

    Waldemar Link is recalling Endo-Model Replacement Plateau implants because the bushing could detach from the screw shaft due to a longitudinal fracture. This could compromise implant stability.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2026·2026-03-18

    Endo-Model Replacement Plateau Orthopedic Implants Recalled for Screw Bushing Detachment

    Waldemar Link is recalling 3 units of Endo-Model Replacement Plateau orthopedic implants due to potential detachment of the bushing from the screw shaft. The defect results from a longitudinal fracture in the screw.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/16;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2026·2026-03-18

    Endo-Model Replacement Plateau Screw Recalled for Bushing Detachment Risk

    Waldemar Link recalls its Endo-Model Replacement Plateau due to potential bushing detachment from the screw shaft, which could cause implant failure. Four units were affected and distributed worldwide.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8030/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2026·2026-03-18

    Endo-Model SL Connection Component recalled for potential bushing fracture

    Waldemar Link is recalling the Endo-Model SL Connection Component orthopedic implant due to potential detachment of the plateau screw bushing from the shaft caused by longitudinal fracture. The recall affects 49 units distributed worldwide.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2026·2026-03-18

    Endo-Model Replacement Plateau implant may experience bushing detachment from fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau implants because the bushing could detach from the screw shaft due to a longitudinal fracture. This mechanical failure could compromise the implant's integrity.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2026·2026-03-18

    Endo-Model Replacement Plateau implant screw bushing may detach

    Waldemar Link's Endo-Model Replacement Plateau knee implant is recalled because the bushing on the plateau screw could detach due to longitudinal fracture. Eight units with specific lot numbers were distributed globally.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/09;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2026·2025-12-17

    Knee Fusion Nail With Incorrectly Assembled Locking Screw

    A knee fusion nail component was distributed with a locking screw incorrectly inserted from the wrong side into the taper. This manufacturing defect could compromise proper implant fixation and stability.

    Product
    Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2541-2025·2025-09-17

    LinkSymphoKnee Tibial Component Recalled Due to Uncoated Security Screws

    Waldemar Link is recalling 8 LinkSymphoKnee knee prosthetic components manufactured with uncoated security screws instead of coated screws. Uncoated screws in the implant present a risk of corrosion and potential implant failure.

    Product
    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2025·2025-08-20

    Hip Prosthesis Labeling Has Inconsistent Size Terminology and Color Coding

    Waldemar Link is recalling 46 units of Prosthesis Head B due to inconsistent size terminology and color coding on labeling, which could lead to confusion during product selection.

    Product
    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2025·2025-08-20

    Plastic Trial Head Surgical Device Recalled for Inconsistent Labeling

    Waldemar Link GmbH recalls plastic trial head components due to inconsistent size terminology and color coding on labeling. The inconsistency could lead to incorrect component selection during surgical procedures.

    Product
    Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2025·2025-05-07

    Knee Replacement Femoral Augment Screw Delivered Missing Thread

    Waldemar Link femoral augment screws for knee replacement surgery were distributed preassembled but missing the thread needed for proper attachment. Affected units shipped nationwide to 17 states.

    Product
    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment Screw Missing Thread Defect

    Waldemar Link is recalling 1,180 Distal Femoral Augments used in knee replacement surgery because the preassembled augment screw is missing its securing thread, which could prevent proper attachment during implantation.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment Femoral Screw Recalled for Missing Thread

    Waldemar Link is recalling Tibial Augment medical devices because preassembled Femoral Augment screws are missing their threads, preventing proper fixation. The recall affects 1771 units distributed nationwide.

    Product
    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2025·2025-05-07

    Posterior Femoral Augment Surgical Implant with Missing Screw Thread Recalled

    Waldemar Link is recalling Posterior Femoral Augment orthopedic implants distributed nationwide due to missing threads on preassembled screws. Patients should contact their surgeon immediately.

    Product
    Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1373-2025·2025-03-26

    Hip Prosthetic Stem Recalled for Incorrect Product Code Label

    A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2025·2025-03-26

    Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier

    37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
    Category
    Medical Device
    Distribution
    Distributed nationwide