Recall

waldemar link gmbh & co. kg (mfg site)

20 recalls on record

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

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.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

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.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

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.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-2836/11;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-8521/09;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-8521/11;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-0027/12;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-2835/12;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-8030/12;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-8521/15;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-0027/15;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-0027/16;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model Replacement Plateau; Item Number: 15-0027/11;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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Waldemar Link GmbH & Co. KG (Mfg Site) — 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 device

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.

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Waldemar Link GmbH & Co. KG (Mfg Site) — LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

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