Stryker Corporation is recalling 44,099 units of various Disposable Spetzler-Malis Bipolar Forceps due to a labeling error regarding the product's shelf life. While the product labels indicate a 54-month (4.5 year) shelf life, the products are actually only validated for a 36-month (3 year) shelf life. These surgical devices were distributed nationwide and internationally between April 2020 and December 2020.
Using the forceps beyond their validated 3-year shelf life may result in the degradation of the device's sterile barrier or mechanical integrity, potentially leading to surgical site infections or device failure during a procedure.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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