Inspire Medical Systems Inc.: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063

Hazard

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

Details from the source

Reason for recall: Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong. Quantity: 10 impacted units Lot/code info: Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959

UPC codes

10855728005793, 10810098650295

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.