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Waldemar Link GmbH & Co. KG (Mfg Site) FDA Recalls
62 recalls on file across devices, 0 of them Class I and 62 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16Class IIJul 6, 2026The affected Endo-Model replacement set for a Rotating Hinge |
| Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;Class IIFeb 11, 2026The surgical technique for the Embrace Shoulder Instruments |
| Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;Class IIFeb 11, 2026The surgical technique for the Embrace Shoulder Instruments |
| Endo-Model Replacement Plateau; Item Number: 15-0027/16;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-8521/15;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-8521/09;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-8521/11;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-8030/12;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-2836/11;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-0027/15;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-2835/12;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-0027/11;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo-Model Replacement Plateau; Item Number: 15-0027/12;Class IIJan 12, 2026The potential for an implant with a plateau screw where the |
| Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compoClass IINov 10, 2025The device has been delivered with a preassembled locking sc |
| LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/Class IIJul 31, 2025Some modular LinkSymphoKnee TiNbN Tibial Components were man |
| Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.Class IIJul 15, 2025Inconsistent size terminology and color coding used on label |
| Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.Class IIJul 15, 2025Inconsistent size terminology and color coding used on label |
| Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3)Class IIApr 3, 2025The device was delivered with a preassembled Femoral Augment |
| Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88Class IIApr 3, 2025The device was delivered with a preassembled Femoral Augment |
| 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-Class IIApr 3, 2025The device was delivered with a preassembled Femoral Augment |
| L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) Class IIApr 3, 2025The device was delivered with a preassembled Femoral Augment |
| Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11Class IIFeb 14, 2025A problem was discovered during the scanning process of the |
| Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13Class IIFeb 14, 2025A problem was discovered during the scanning process of the |
| Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12Class IIFeb 14, 2025A problem was discovered during the scanning process of the |
| LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,Class IIDec 5, 2024Error on the main label and the patient label. The labels in |
| Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-281Class IIMay 22, 2024Blind screws of the modular tibial component cannot be loose |
| Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial ComponeClass IIMay 22, 2024Blind screws of the modular tibial component cannot be loose |
| SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cementedClass IIFeb 6, 2024Due to two complaints, has come to our attention that additi |
| SPII Model Lubinus, Long Stem Prosthesis XL Neck, cementedClass IIFeb 6, 2024Due to two complaints, has come to our attention that additi |
| SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cementedClass IIFeb 6, 2024Due to two complaints, has come to our attention that additi |
| SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cementedClass IIFeb 6, 2024Due to two complaints, has come to our attention that additi |
| Embrace Drill Tower, Wedged (25mm)Class IIJan 29, 2024The surgical techniques for the Embrace Shoulder Instruments |
| Embrace Drill Tower, Standard/Lateral (25mm)Class IIJan 29, 2024The surgical techniques for the Embrace Shoulder Instruments |
| LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limitingClass IIJan 22, 2024Mislabeled: Packaging incorrectly reflects a MobileLink Dual |
| Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplaClass IINov 30, 2023Mislabeled: Angle and height of the device marked as L(large |
| Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implaClass IIJul 26, 2023A crack in the weld of the rasp handle may lead to a fractur |
| MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees InclinaClass IIJul 14, 2023Product is labeled with incorrect offset. |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fracClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fracClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, frClass IIJul 3, 2023Increased force may be required to remove the LINK MP Monobl |
| LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and reClass IIDec 23, 2022Fixation screw was inserted through the wrong side of the au |
| LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and reClass IIDec 23, 2022Fixation screw was inserted through the wrong side of the au |
| Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817Class IIMay 24, 2022There is a risk that blind screws of the modular tibial comp |
| Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Class IIMay 24, 2022There is a risk that blind screws of the modular tibial comp |
| Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Class IIMay 24, 2022There is a risk that blind screws of the modular tibial comp |
| Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #Class IIMay 24, 2022There is a risk that blind screws of the modular tibial comp |
| LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, LeftClass IIMar 18, 2021The firm discovered through customer complaints that device |
| LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, LeftClass IIMar 18, 2021The firm discovered through customer complaints that device |
| LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, RightClass IIMar 18, 2021The firm discovered through customer complaints that device |
| LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, RightClass IIMar 18, 2021The firm discovered through customer complaints that device |