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

  • Severity pendingFDA (Devices)·Z-1520-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-8521/15;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1520-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1519-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-8521/11;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1519-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1512-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-0027/15;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1512-2026.

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

    Endo-Model Replacement Plateau; Item Number: 15-0027/16;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1523-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/16;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1518-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-8521/09;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1518-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/09;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1521-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-0027/11;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1521-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1517-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-8030/12;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1517-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8030/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1515-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-2835/12;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1515-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2835/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1522-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-0027/12;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1522-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1516-2026·2026-03-18

    Endo-Model Replacement Plateau; Item Number: 15-2836/11;

    Pending LLM rewrite. Source: FDA_DEVICE Z-1516-2026.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2836/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    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
  • SevereFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment devices recalled for missing screw thread

    Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

    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
  • SevereFDA (Devices)·Z-1700-2025·2025-05-07

    Posterior Femoral Augment with Missing Screw Thread Recalled

    Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.

    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
  • SevereFDA (Devices)·Z-1701-2025·2025-05-07

    L-Shaped Femoral Augment with Missing Screw Thread

    Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments because the preassembled femoral augment screw was missing its thread. The defect could affect the device's structural integrity during orthopedic surgery.

    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
  • ModerateFDA (Devices)·Z-1374-2025·2025-03-26

    Modular Stem Orthopedic Implants Recalled for Incorrect GTIN Labeling

    Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
    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