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Inspire Medical Systems Inc.: Brand Name: Inspire Medical Systems, Inc. Product

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: 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.. Recalled by Inspire Medical Systems Inc.. Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.. Classification (Class II — potential health risk). Affected lots/dates: Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbe. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, repair, or repla

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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