Waldemar Link GmbH & Co. KG (Mfg Site)
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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: 15-0027/16;
Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →