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Waldemar Link GmbH & Co. KG (Mfg Site) Recalls
65 recalls on record · January 23, 2019 to August 19, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Hazard: The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
April 1, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Hazard: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
April 1, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Hazard: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
December 17, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compo
Hazard: The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
September 17, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/
Hazard: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
August 20, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Hazard: Inconsistent size terminology and color coding used on labeling
August 20, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Hazard: Inconsistent size terminology and color coding used on labeling
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls 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-
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3)
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3)
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
March 26, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Hazard: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
March 26, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Hazard: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
March 26, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Hazard: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
January 1, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,
Hazard: Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
July 24, 2024Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Compone
Hazard: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
July 24, 2024Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-281
Hazard: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique