Smith & Nephew, Inc. has recalled 75 META-TAN Integrated Lag/Compression Screw Kits because the compression screw may have an undersized hexagon socket. This defect makes the screw non-functional and requires surgeons to find and prepare an alternative screw during a procedure. This exchange process can significantly delay surgeries, often extending the operation time by more than 30 minutes.
The undersized socket prevents the screw from being properly used during surgery, leading to unexpected delays while a replacement is sourced. These delays increase the amount of time a patient spends under anesthesia, which can elevate the risk of surgical complications.
REF: 71642690
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Sources: FDA iRES · Raw API Response
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