FDA (Devices) recall action 84004
The FDA (Devices) publishes a recall like this one as 31 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 31 pages.
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
The agency’s own wording, quoted from the enforcement report.
Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.
Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.
Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.
Orthofix Srl is recalling Tibia Femur Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.
Orthofix Srl is recalling specific lots of Radiolucent Wrist Fixator Kits because drill bits have a design defect that may reduce cutting performance.
Orthofix is recalling XCaliber Ankle Complete Kits because drill bits have a design defect that may reduce cutting performance.