Waldemar Link And Kg Mfg Site recalls
Waldemar Link And Kg Mfg Site appears in 65 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site
Reason: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this iss… - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site
Reason: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this iss… - LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee r…
FDA Device · Class II · 2023-07-12 · Waldemar Link And Kg Mfg Site
Reason: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). - LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee r…
FDA Device · Class II · 2023-07-12 · Waldemar Link And Kg Mfg Site
Reason: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). - LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
FDA Device · Class II · 2023-07-05 · Waldemar Link And Kg Mfg Site
Reason: The firm discovered through customer complaints that device segments may not meet specifications. - LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
FDA Device · Class II · 2023-07-05 · Waldemar Link And Kg Mfg Site
Reason: The firm discovered through customer complaints that device segments may not meet specifications. - LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
FDA Device · Class II · 2023-07-05 · Waldemar Link And Kg Mfg Site
Reason: The firm discovered through customer complaints that device segments may not meet specifications. - LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
FDA Device · Class II · 2023-07-05 · Waldemar Link And Kg Mfg Site
Reason: The firm discovered through customer complaints that device segments may not meet specifications. - Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site
Reason: 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. - Tibial Component Modular. orthopedic prosthesis
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site
Reason: 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. - Tibial Component. orthopedic prosthesis
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site
Reason: 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. - Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthop…
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site
Reason: 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. - BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with m…
FDA Device · Class II · 2019-01-23 · Waldemar Link And Kg Mfg Site
Reason: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. - LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Pro…
FDA Device · Class II · 2019-01-23 · Waldemar Link And Kg Mfg Site
Reason: 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… - BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with m…
FDA Device · Class II · 2019-01-23 · Waldemar Link And Kg Mfg Site
Reason: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.