1,011 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018
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, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024
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
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code FZX·November 30, 2023
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·July 31, 2025
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
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·July 3, 2023
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
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·January 22, 2024
Embrace Drill Tower, Wedged (25mm)
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code HTW·January 29, 2024
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JDG·February 6, 2024
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JDG·February 6, 2024
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
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·July 3, 2023
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 24, 2022
Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 24, 2022
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code HTW·February 11, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code HTW·February 11, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026