Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
Reason for recall: Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery. Distribution: US Nationwide distribution in the state of Alabama. Quantity: 14 units Lot/code info: UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
00615521000851
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.