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414 results
Smith & Nephew, Inc. · Knee implants
FDA device identifier records list ZUK under Smith & Nephew, Inc.. This page lists 60 device model identifiers in Knee implants; source families may also contain components and instruments. UDI listing identifies products; it does not establish FDA approval or recall status.
Latest source check Oct 27, 2026
FDA · FDA event 99692
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Posted Oct 6, 2026
FDA · FDA event 99818
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users…
Posted Oct 5, 2026
FDA · FDA event 99589
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in…
Posted Sep 29, 2026
FDA · FDA event 99643
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until…
Posted Sep 18, 2026
FDA · FDA event 99557
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Posted Aug 31, 2026
FDA · FDA event 99445
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Posted Aug 19, 2026
FDA · FDA event 99374
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic…
Posted Aug 18, 2026
FDA · FDA event 99405
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be…
Posted Aug 11, 2026
FDA · FDA event 99304
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Posted Jul 28, 2026