Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Check against the official notice below — it lists the full affected range.
Flower Orthopedics Corporation is recalling 48 units of the Flex-Thread Inserter Shaft intended for fibula intramedullary procedures (Lot Number 11090, UDI: 00840118117548). The device is designed to be used with an Inserter Draw Rod and Blue Ratchet Handle to facilitate insertion during surgery. The recalled units have a mating incompatibility between the Inserter Shaft and the Inserter Draw Rod that causes the draw rod to bind and not rotate freely as intended.
This malfunction could prevent surgeons from completing procedures unless a second set of instruments is available. The affected devices were distributed nationwide to medical facilities in Arizona, California, Colorado, Georgia, Tennessee, Florida, Illinois, Massachusetts, Maryland, North Carolina, and Texas. The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
Reason for recall: Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available Distribution: US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX. Quantity: 48 units Lot/code info: Lot Number: 11090 UDI: 00840118117548
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.