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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.
July 20, 2022Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11,
Hazard: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
July 20, 2022Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #
Hazard: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
January 23, 2019Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Nu
Hazard: The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
January 23, 2019Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicat
Hazard: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
January 23, 2019Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicat
Hazard: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.