Waldemar Link GmbH & Co. KG (Mfg Site) recalls
8 recalls on record · FDA
Every recall we have on record for Waldemar Link GmbH & Co. KG (Mfg Site), compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2)…
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12…
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for…
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 …
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.