The Recall Desk

Manufacturer

Waldemar Link GmbH & Co. KG (Mfg Site)

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

What the numbers show

Total
65
Critical
0
Severe
4
Most recent
2026-08-19

Of the 65 recalls from Waldemar Link GmbH & Co. KG (Mfg Site) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) 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.

1–25 of 65

  • HighFDA (Devices)·Z-2934-2026·2026-08-19

    Waldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets

    Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.

    Product
    Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1652-2026·2026-04-01

    Embrace standard drill tower surgical technique lists mixed-up article numbers

    Waldemar Link is recalling the Embrace Drill Tower, Standard/Lateral, because the surgical technique document has mixed-up article numbers in the instrument overview, although the surgical steps are correct.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1651-2026·2026-04-01

    Embrace shoulder drill tower surgical technique lists mixed-up article numbers

    Waldemar Link is recalling the Embrace Drill Tower because the surgical technique document has mixed-up article numbers in the instrument overview, although the individual surgical steps are correct.

    Product
    Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1520-2026·2026-03-18

    Link Endo-Model plateau 15-8521/15 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2026·2026-03-18

    Link Endo-Model plateau 15-0027/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2026·2026-03-18

    Link Endo-Model SL component 16-2840/02 recalled over bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/02 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2026·2026-03-18

    Link Endo-Model plateau 15-2836/11 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2836/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2836/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2026·2026-03-18

    Link Endo-Model plateau 15-8521/11 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

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

    Link Endo-Model plateau 15-0027/15 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

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

    Link Endo-Model plateau 15-8521/09 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/09 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

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

    Link Endo-Model plateau 15-0027/11 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2026·2026-03-18

    Link Endo-Model plateau 15-2835/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2835/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2835/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2026·2026-03-18

    Link Endo-Model plateau 15-0027/16 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/16 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/16;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2026·2026-03-18

    Link Endo-Model SL connection component recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/07 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2026·2026-03-18

    Link Endo-Model SL component 16-2840/05 recalled over bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/05 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2026·2026-03-18

    Link Endo-Model plateau 15-8030/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8030/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8030/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2026·2025-12-17

    Adhesive bandages recalled over open package seals that may compromise sterility

    Medline is recalling 1,566,500 Fur Friends Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    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

    Knee tibial components recalled because security screws were left uncoated

    LinkSymphoKnee modular TiNbN tibial components, size 5, REF 880-100/50, are recalled because some were manufactured with two uncoated security screws. 8 units are affected.

    Product
    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2289-2025·2025-08-20

    Plastic trial heads carry inconsistent size terminology and color coding

    Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.

    Product
    Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2288-2025·2025-08-20

    Prosthesis heads carry inconsistent size terminology and color coding on labeling

    Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.

    Product
    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
    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
  • 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
  • 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