Waldemar Link Gmbh & Co. Kg
Oststrasse 4-10, Norderstedt Schleswig-Holstein, DE
Registered product codes
68 product codes
Recent MDR events
778 on file
- LinkSymphoKneeJul 27, 2026Injury3004371426-2026-00057
- LinkSymphoKneeJul 10, 2026Injury3004371426-2026-00055
- LINKSYMPHOKNEEJul 10, 2026Injury3004371426-2026-00051
- LINK SLEDJul 10, 2026Injury3004371426-2026-00054
- ENDO-MODELJul 9, 2026Malfunction3004371426-2026-00053
- ENDO-MODEL SADDLE PROSTHESISJul 9, 2026Injury3004371426-2026-00056
- ENDO-MODEL SADDLE PROSTHESISJul 6, 2026Injury3006721341-2026-00014
- LINK SLED PROSTHESISJun 30, 2026Injury3004371426-2026-00050
- ENDO-MODEL SLJun 24, 2026Injury3004371426-2026-00052
- LINK EMBRACE SHOULDER SYSTEMJun 23, 2026Injury3006721341-2026-00013
Recalls
87 on file
- Open, ClassifiedAug 11, 2026
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗ - Open, ClassifiedMar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
View FDA record ↗
Compliance history
Matched by FEI 3003386935.
FDA inspections
2 on file
- No Action Indicated (NAI)Feb 19, 2026
Compliance: Devices
- No Action Indicated (NAI)Feb 19, 2026
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.