Manufacturer

Waldemar Link GmbH & Co. KG (Mfg Site)

61 recalls in our database name Waldemar Link GmbH & Co. KG (Mfg Site) as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–61 of 61

ModerateFDA (Devices)·Z-2349-2023·2023-08-16
Hip Stem Trial Instrument Difficult to Remove After Impaction
LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.
Product
LINK 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2067-2023·2023-07-12
LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation
Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.
Product
LinkSymphoKnee 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2023·2023-07-12
LinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement
The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.
Product
LinkSymphoKnee 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2046-2023·2023-07-05
Knee Prosthesis System Components Recalled for Specification Non-Compliance
Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2048-2023·2023-07-05
Knee prosthesis femoral segment recalled for specification non-compliance
Waldemar Link is recalling 16 units of a knee prosthesis femoral segment due to specification non-compliance discovered through customer complaints. Patients and healthcare facilities should contact the manufacturer for guidance.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2049-2023·2023-07-05
LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects
The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2047-2023·2023-07-05
Knee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1377-2022·2022-07-20
Modular Orthopedic Implant Screws May Not Loosen During Surgery
FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.
Product
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1378-2022·2022-07-20
Modular orthopedic prosthesis recall due to intraoperative component locking
Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.
Product
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1379-2022·2022-07-20
Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect
Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.
Product
Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1380-2022·2022-07-20
Tibial Prosthetic Component Recall: Blind Screws Cannot Be Loosened Intraoperatively
Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.
Product
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Category
Medical Device
Distribution
15 states