Recall Z-0260-2025 — Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or
U.S. FDA — Device Enforcement · United States · 2024-09-03 · Class III
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Reported risk: The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.
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