Waldemar Link GmbH & Co. KG (Mfg Site)
41 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Waldemar Link GmbH & Co. KG (Mfg Site) and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-08-16FDA-DeviceClass IILINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
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 issue
- 2023-08-16FDA-DeviceClass IILINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
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 issue
- 2023-08-16FDA-DeviceClass IILINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
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 issue
- 2023-08-16FDA-DeviceClass IILINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
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 issue
- 2023-08-16FDA-DeviceClass IILINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
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 issue
- 2023-07-12FDA-DeviceClass IILinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
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).
- 2023-07-12FDA-DeviceClass IILinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
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).
- 2023-07-05FDA-DeviceClass IILINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
The firm discovered through customer complaints that device segments may not meet specifications.
- 2023-07-05FDA-DeviceClass IILINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
The firm discovered through customer complaints that device segments may not meet specifications.
- 2023-07-05FDA-DeviceClass IILINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
The firm discovered through customer complaints that device segments may not meet specifications.
- 2023-07-05FDA-DeviceClass IILINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
The firm discovered through customer complaints that device segments may not meet specifications.
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