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.

26–50 of 61

ModerateFDA (Devices)·Z-1372-2025·2025-03-26
Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier
37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0769-2025·2025-01-01
Hip Reconstruction System Component Mislabeled for Size
Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.
Product
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadeq
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2410-2024·2024-07-24
Knee Prosthesis Tibial Component Screws Cannot Be Loosened During Surgery
The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.
Product
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2411-2024·2024-07-24
Endo Model SL Tibial Components Recalled for Inoperable Blind Screws
Waldemar Link is recalling Endo Model SL Tibial Components used in knee replacement surgery because the blind screws on the modular components cannot be loosened during surgery, potentially prolonging procedures and forcing surgeons to change their planned approach.
Product
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1296-2024·2024-03-20
Hip Prosthesis Stem Labels Lack Clear Guidance on Size and Type
A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.
Product
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1299-2024·2024-03-20
SPII Lubinus Hip Prosthesis Recalled Due to Carton Label Interpretation Guidance
Waldemar Link is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck implants due to carton labeling that could be misinterpreted during surgery. Clearer guidance is being provided to prevent surgical misapplication.
Product
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1297-2024·2024-03-20
Hip prosthesis labeling guidance issue affects 34 units
The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.
Product
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1298-2024·2024-03-20
Hip prosthesis labeling clarification needed to prevent surgical confusion
Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.
Product
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1257-2024·2024-03-13
Embrace Drill Tower Shoulder Instruments Recalled for Mislabeled Type Descriptions
Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.
Product
Embrace Drill Tower, Wedged (25mm)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1258-2024·2024-03-13
Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions
Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.
Product
Embrace Drill Tower, Standard/Lateral (25mm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1219-2024·2024-03-06
Hip Implant Component Mislabeled With Wrong Insert Type on Packaging
LINK BiMobile hip implant liners are being recalled because packaging incorrectly identifies the insert type as F instead of G. This labeling error could delay surgery or result in the wrong component being used.
Product
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0749-2024·2024-01-24
Link Patella Glide Resection Guide recalled due to size mislabeling
A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.
Product
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2641-2023·2023-10-04
MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling
Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.
Product
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2481-2023·2023-09-06
Surgical Rasp Handle May Fracture Due to Weld Crack
The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.
Product
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2355-2023·2023-08-16
LINK MP Hip Stem Trial Instruments difficult to remove after implantation
The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2023·2023-08-16
LINK MP Hip Stem trial instruments may require increased removal force during surgery
LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2023·2023-08-16
Medical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk
Waldemar Link GmbH recalls LINK MP Monoblock hip stem trial instruments due to increased removal force requirements after impaction, which may prolong surgery or require procedural modification.
Product
LINK 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2354-2023·2023-08-16
LINK MP Monoblock Hip Stem trial instruments recalled for increased removal difficulty
Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2023·2023-08-16
Hip implant trial stem: increased removal force may extend surgery
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2023·2023-08-16
Hip Stem Trial Implant May Require Excessive Force During Removal
A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical modification.
Product
LINK 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2350-2023·2023-08-16
Hip stem trial instruments recalled due to excessive removal force
LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2023·2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2023·2023-08-16
LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal
Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.
Product
LINK 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2023·2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force
LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.
Product
LINK 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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2353-2023·2023-08-16
LINK MP Hip Stem Difficult to Remove After Surgical Implantation
Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
Category
Medical Device
Distribution
Distributed nationwide